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D009203: Myocardial Ischemia

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (49)


Name (Synonyms) Correlation
drug611 Biological data Wiki 0.30
drug1004 Clinical data Wiki 0.25
drug3559 RUC-4 Compound Wiki 0.21
Name (Synonyms) Correlation
drug2088 Immunological profiling Wiki 0.21
drug229 Ad5FGF-4 Wiki 0.21
drug166 AVP 4 Wiki 0.21
drug4317 Telemedicine follow-up visit Wiki 0.21
drug167 AVP I Wiki 0.21
drug4768 Xpert Pro stent Wiki 0.21
drug3074 Pacel BPC Wiki 0.21
drug1396 DynamX Bioadaptor Wiki 0.21
drug2679 Motivational social support from nurse with additional support from significant other Wiki 0.21
drug60 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients) Wiki 0.21
drug28 12 weeks of bicycle exercise Wiki 0.21
drug3075 Pacel FDPC Wiki 0.21
drug3663 Resolute Onyx Wiki 0.21
drug2082 Immunfluorescence Wiki 0.21
drug424 Attention control Wiki 0.21
drug61 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) Wiki 0.21
drug311 Angiography Wiki 0.21
drug2678 Motivational social support from nurse Wiki 0.21
drug3466 QFR Wiki 0.21
drug4319 Telemedicine visit Wiki 0.21
drug3722 Robot Assisted Percutaneous Cardiovascular Intervention Wiki 0.21
drug2081 Immune response study Wiki 0.21
drug4305 Tele-medicine platform Wiki 0.21
drug35 18F-GP1 PET CT Wiki 0.21
drug197 Absolute Pro LL stent Wiki 0.21
drug2463 MI-CBT Wiki 0.21
drug2100 Inactivated SARS CoV 2 vaccine (Vero cell). Wuhan Wiki 0.21
drug3376 PressureWire X Wiki 0.21
drug33 18F-DX600 PET/CT Wiki 0.21
drug4184 Supera 7.5 OD stent Wiki 0.21
drug2488 MULTI-LINK 8 SV stent Wiki 0.21
drug2487 MULTI-LINK 8 LL stent Wiki 0.21
drug4764 XIENCE PRIME BTK stent Wiki 0.21
drug2489 MULTI-LINK 8 stent Wiki 0.21
drug3132 Percutaneous Coronary Revascularization for STEMI Wiki 0.21
drug168 AVP II Wiki 0.21
drug640 Blood Transfusion Wiki 0.21
drug4872 cardiac magnetic resonance Wiki 0.21
drug2097 In-person in clinic follow-up visit Wiki 0.21
drug2099 In-person postoperative visit Wiki 0.21
drug72 50 mg/mL Virazole Wiki 0.15
drug26 100 mg/mL Virazole Wiki 0.15
drug4857 blood donation SMS Wiki 0.12
drug554 Baricitinib Wiki 0.08
drug2827 No intervention Wiki 0.04
drug3195 Placebo Wiki 0.01

Correlated MeSH Terms (42)


Name (Synonyms) Correlation
D007238 Infarction NIH 0.77
D003324 Coronary Artery Disease NIH 0.50
D003327 Coronary Disease NIH 0.40
Name (Synonyms) Correlation
D000787 Angina Pectoris NIH 0.30
D002546 Ischemic Attack, Transient NIH 0.30
D007511 Ischemia NIH 0.30
D054143 Heart Failure, Systolic NIH 0.30
D006331 Heart Diseases NIH 0.28
D054058 Acute Coronary Syndrome NIH 0.26
D000072657 ST Elevation Myocardial Infarction NIH 0.25
D013610 Tachycardia NIH 0.25
D016757 Death, Sudden, Cardiac NIH 0.21
D023921 Coronary Stenosis NIH 0.21
D023903 Coronary Restenosis NIH 0.21
D002561 Cerebrovascular Disorders NIH 0.21
D019462 Syncope, Vasovagal NIH 0.21
D013575 Syncope NIH 0.21
D054144 Heart Failure, Diastolic NIH 0.21
D013616 Tachycardia, Sinus NIH 0.21
D017180 Tachycardia, Ventricular NIH 0.21
D060050 Angina, Stable NIH 0.21
D004617 Embolism NIH 0.20
D011655 Pulmonary Embolism NIH 0.16
D007022 Hypotension NIH 0.15
D009205 Myocarditis NIH 0.13
D015673 Fatigue Syndrome, Chronic NIH 0.12
D013927 Thrombosis NIH 0.12
D016584 Panic Disorder NIH 0.11
D016769 Embolism and Thrombosis NIH 0.11
D003643 Death, NIH 0.11
D001281 Atrial Fibrillation NIH 0.11
D014652 Vascular Diseases NIH 0.11
D006333 Heart Failure NIH 0.11
D020521 Stroke NIH 0.10
D005356 Fibromyalgia NIH 0.10
D054556 Venous Thromboembolism NIH 0.07
D020246 Venous Thrombosis NIH 0.06
D013923 Thromboembolism NIH 0.05
D058186 Acute Kidney Injury NIH 0.04
D013577 Syndrome NIH 0.04
D002318 Cardiovascular Diseases NIH 0.03
D004194 Disease NIH 0.03

Correlated HPO Terms (21)


Name (Synonyms) Correlation
HP:0001658 Myocardial infarction HPO 0.95
HP:0001677 Coronary artery atherosclerosis HPO 0.50
HP:0001681 Angina pectoris HPO 0.30
Name (Synonyms) Correlation
HP:0002326 Transient ischemic attack HPO 0.30
HP:0001649 Tachycardia HPO 0.25
HP:0005145 Coronary artery stenosis HPO 0.21
HP:0012668 Vasovagal syncope HPO 0.21
HP:0011703 Sinus tachycardia HPO 0.21
HP:0001279 Syncope HPO 0.21
HP:0004756 Ventricular tachycardia HPO 0.21
HP:0001645 Sudden cardiac death HPO 0.21
HP:0002204 Pulmonary embolism HPO 0.16
HP:0002615 Hypotension HPO 0.15
HP:0012819 Myocarditis HPO 0.13
HP:0004757 Paroxysmal atrial fibrillation HPO 0.11
HP:0001635 Congestive heart failure HPO 0.11
HP:0001297 Stroke HPO 0.10
HP:0001907 Thromboembolism HPO 0.09
HP:0002625 Deep venous thrombosis HPO 0.06
HP:0001919 Acute kidney injury HPO 0.04
HP:0001626 Abnormality of the cardiovascular system HPO 0.03

Clinical Trials

Navigate: Correlations   HPO

There are 22 clinical trials


1 Essential Arterial Hypotension and Allostasis Registry

The essential arterial hypotension and allostasis registry is a prospective, observational research that has the purpose of demonstrating that essential blood pressure (BP) disorders and the associated comorbidities are a result of the inappropriate allostatic response to daily life stress. This required a functioning brain orchestrating the evaluation of the threat and choosing the response, this is a mind-mediated phenomenon. If the response is excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify the allostatic pattern, which in turn will play an important role in the development of the comorbidities. To do so, consecutive patients of any age and gender that visit a cardiologist's office in Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP and allostasis and follow them in time to see what kind of diseases develops the most (including BP) in the follow up according to the categorization of the characteristic chosen and after adjustment for confounder's variables. In addition, stress events with their date are registered. HYPOTHESIS The causes of the diseases are multifactorial. Physical, biochemical, psychological, social, and cultural dimensions of development dynamically interact to shape the health development process. A person´s health depends on their: 1. Biological and physiologic systems 2. External and internal environment (a) physical, b) internal behavioural and arousal state as registered by the brain. 3. Their interaction. The allostatic mechanisms to the internal and external stressors (allostatic load) involves a network composed by: 1. Functional systems; mediated by: 1. The Autonomic Nervous System 2. The endocrine system 3. The immune system 2. Structural changes: whenever the internal and/or external stressors are long lasting and/or strength enough, they may induce changes in: 1. Epigenetic, endophenotypes, polyphenism. 2. Plasticity 3. The interaction between a) and b). The network response do not affect exclusively the BP, propitiating the development of comorbidities, which may prompt strategies for prevention, recognition and ultimately, treatment. The allostatic model defines health as a state of responsiveness. The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis) and psychological (psychostasis) abilities. It is proposed that both components behave in similar direction and magnitude. Immune disorders may be associated with the development of cancer. High BP population has a higher sympathetic and lower vagal tone, this has been associated with a decrease in the immune´s system function. Resources and energy depletion: Terms like weathering have been used to describe how exposures to different allostatic loads gradually scrape away at the protective coating that keeps people healthy. It is postulated that High BP individuals have more resources and energy.

NCT02018497
Conditions
  1. Blood Pressure
  2. Depression
  3. Panic Attack
  4. Fibromyalgia
  5. POTS
  6. Inappropriate Sinus Tachycardia
  7. Coronary Heart Disease
  8. Acute Coronary Syndrome (ACS)
  9. Acute Myocardial Infarction (AMI)
  10. Cerebrovascular Disease (CVD)
  11. Transient Ischemic Attack (TIA)
  12. Atrial Fibrillation
  13. Diabetes Mellitus
  14. Cancer
  15. Systolic Heart Failure
  16. Diastolic Heart Failure
  17. Chronic Fatigue Syndrome
  18. Syncope
  19. Vasovagal Syncope
MeSH:Fatigue Syndrome, Chronic Fibromyalgia Syncope Ischemic Attack, Transient Cerebrovascular Disorders Syncope, Vasovagal Heart Failure Atrial Fibrillation Myocardial Infarction Heart Diseases Acute Coronary Syndrome Hypotension Coronary Disease Tachycardia Heart Failure, Diastolic Heart Failure, Systolic Tachycardia, Sinus Syndrome Panic Disorder
HPO:Abnormal left ventricular function Atrial fibrillation Carotid sinus syncope Congestive heart failure Hypotension Myocardial infarction Paroxysmal atrial fibrillation Right ventricular failure Sinus tachycardia Syncope Tachycardia Transient ischemic attack Vasovagal syncope

Primary Outcomes

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality

Measure: Relationship between Blood pressure group and comorbidities

Time: A 7-year prospective study

Description: Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality

Measure: Relationship between adaptability group and comorbidities

Time: A 7-year prospective study

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality

Measure: Relationship between blood pressure group, adaptability group and comorbidities

Time: A 7-year prospective study

Secondary Outcomes

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, homoeostasis model assessment (HOMA), total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: HR; PR interval, QRS complex, cQT interval Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Measure: Relationship between blood pressure group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM)

Time: A 7-year prospective study

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Measure: Relationship between blood pressure group, adaptability group, habits anthropometric, metabolic, endocrine, electrocardiographic, Holter, ambulatory arterial blood pressure monitoring.

Time: A 7-year prospective study

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: 1) Hyper adaptable, 2) normal adaptability and 3) hypo adaptable. Habits: smoke and drink, exercise Anthropometric variables: Body mass index, waist, hip Metabolic and other variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides; thyrotropine, Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Measure: For metabolic disorders what it matters the most: the anthropometric variables vs blood pressure group vs adaptability group

Time: A 7-year prospective study

Description: Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Measure: Relationship between adaptability group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM)

Time: A 7-year prospective study

Other Outcomes

Description: Clinical syncope characteristics (age of first syncope, number of syncope episodes, trauma, duration, clinical score, convulse, sphincter relaxation, etc.) Syncope cause Blood pressure group Adaptability group Prognosis

Measure: Syncope Registry

Time: Up 100 weeks

Description: TTT protocol: describe the protocol, the time at positive response, nitroglycerine use, autonomic and hemodynamic variables. TTT outcome for syncope: positive or negative TTT other outcomes: 1) Chronotropic incompetence, 2) arterial orthostatic hypotension, 3) carotid hypersensitivity, 4) POTS, 5) IST The relationship between TTT results and Clinical score for syncope in regard to: syncope behaviour and other orthostatic intolerance entities, symptoms and comorbidities. The relationship between neurally mediated syncope response at the TTT and comorbidities.

Measure: Tilt table testing (TTT) registry

Time: Up to 100 weeks

Description: EPS variables: AH, AV, CL, sino atrial conduction time (SACT), sinus node recovery time (SNRT), corrected sinus node recovery time (CSNRT), response to Isoproterenol, intrinsic heart rate Diagnosis: control, sick sinus syndrome, IST, chronotropic incompetence at the TTT HR at the ECG HR at the Holter monitoring HR at the TTT HRV at the Holter monitoring Syncope, cardiac or neurally mediated HR at the physical treadmill test Relationship with the blood pressure group Relationship with the adaptability group

Measure: Sinus node function at the electrophysiological study (EPS)

Time: Up to 100 weeks

Description: Define how the blood pressure group and/or the adaptability group may add to the already known and include in this registry, in the diagnosis of cardiovascular complications as coronary artery disease, cerebrovascular disease, peripheral artery disease, nephropathy.

Measure: Score for coronary artery disease

Time: Up to 200 weeks

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, COPD, and others. Mortality

Measure: Neurally Mediated Syncope: further of the transient lost of consciousness (TLC)

Time: A 7-year prospective study

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Psychiatric variables: Big Five Questionary (BFQ) for personality. Modify of the Coping Scale (Scale of modified coping strategies) Zung questionary for depression and anxiety MINI in those patients with moderate or severe depression and/or anxiety at the Zung questionary

Measure: Psychobiotype: relationship between biological and psychological variables

Time: Up to 100 weeks

Description: High sodium intake in the diet is recognized as a risk factor for hypertension development. Essential hypotension population is advised to increase the sodium (at least 10 grams a day) and water intake (at least 2 liters a day), or as much as possible, several have taken Fludrocortisone (is not a exclusion criteria). Normal blood pressure population are advised to have a normal or low sodium intake. Physical exercise is recommended in both groups. This registry is a good opportunity to test how important sodium diet is to induce hypertension, or if by the contrary adaptability could prevail over high sodium intake in this registry. Blood pressure groups: essential hypotension and normotension and those with new essential hypertension. Adaptability groups. The results will be adjusted for age, gender and BMI.

Measure: The role of high sodium intake in the development of essential hypertension. Comparison between essential hypotension (high sodium intake) vs normotension population (normal or low sodium intake) in the follow-up.

Time: 4 years

Description: Consistent bradycardia in the ECG at the office and normal HR in the holter monitoring or the contrary. There are patients with complaints that may be attributed to bradycardia, low blood pressure, hypothyroidism, or other entities. Some patients very often have bradycardia in the ECG taken in the office and normal HR in the 24 Holter monitoring, the opposite is also possible. Patients with bradycardia (without medication or physiological condition as exersice affecting heart rate) in at least 2 ECG (less 60 bpm) and at least 2 Holter monitoring will be analyzed, Other variables to consider are: Age, gender, blood pressure group, adaptability group, maximum HR in the treadmill test, white coat or masked hypertension, Tilt-Table-test result or syncope cause, Electrophysiological study if available. The acknowledge of this phenomenon could have clinical implications in the diagnosis of sick sinus syndrome and physiopathological ones.

Measure: White coat effect in the heart rate or masked bradycardia.

Time: 1 year

Description: Bradycardia is the classical presentation form for sinus node dysfunction, mainly when associated with symptoms. Chronotropic incompetence is also a manifestation. Absence of medications with effects on the heart rate (HR) must be ruled out. Variables HR at the ECG, Holter monitoring, stress text, and at the physical examination previous to pacemaker implantation, Electrophysiological study (EPS): Basic cycle length, Sino-atrial conduction time, Sinus node recovery time, Corrected sinus node recovery time, Intrinsic HR when available 3. Pacemaker variables: HR at day and night or rest time Percentage of stimulation in A and V chambers 4. Syncope: Clinical characteriscs and clinical score Tilt table test results Trans Thoracic Echocardiogram in rest and or stress text Hypothesis: patients with ANSD will start to decrease the percentage atrial stimulation.

Measure: Reversible Bradycardia Mimicking Sinus Node Dysfunction as a Manifestation of Subacute Autonomic Nervous System Dysfunction (ANSD).

Time: 2 years

Description: A non invasive, beat to beat BP monitoring, with the ability to measure BP, HR, Cardiac Output and Systemic Vascular Resistance (SVR) was started to use in the EHAR registry since May 2017. A description of this variables in the three BP groups will be collected in the data base (DB). This will allow to characterize whether SVR and/or CO maintain BP. Until now BP levels are related with prognosis. In the prognosis model SVR and CO will be add them to know what matter the most: BP levels, SVR and/or CO? In the EHAR registry a collection of the variables recognized as a risk factor for several comorbidities are available to adjust in multivariable analysis.

Measure: Description of the blood pressure hemodynamic profile at a medical office and their prognostic implications.

Time: Three years
2 CSP #599 - Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)

The goal of the proposed study is to determine whether a liberal transfusion strategy (transfusion trigger at Hb < 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb < 7 gm/dl).

NCT03229941
Conditions
  1. Myocardial Infarction
  2. Coronary Revascularization
  3. Acute Renal Failure
Interventions
  1. Procedure: Blood Transfusion
MeSH:Acute Kidney Injury Myocardial Infarction Infarction
HPO:Acute kidney injury Myocardial infarction

Primary Outcomes

Description: MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graft, or percutaneous coronary intervention (either angioplasty or stenting). Stroke will be defined as new unilateral neurological deficit that lasts for more than 24 hours, and is confirmed by a brain imaging modality (computed tomography or magnetic resonance imaging study) demonstrating new brain infarct.

Measure: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization.

Time: 90 days after randomization

Secondary Outcomes

Description: Wound infection will be defined according to the Centers for Disease Control and Prevention (CDC) guidelines as a) positive wound culture, or b) drainage of pus from a wound, or c) suspicion of wound infection that was drained operatively. Pneumonia will be defined according to the CDC definition as chest radiograph with new or progressive infiltrate, consolidation, cavitation, or pleural effusion and any of the following: new onset of purulent sputum or change in character of sputum, or organism isolated from blood culture, trans-tracheal aspirate, bronchial brushings, or biopsy. Sepsis will be defined as a combination of two of the following systemic inflammatory response syndrome (SIRS) criteria, plus suspected or present source of infection. SIRS criteria will include the following: temperature greater than 38C, heart rate greater than 90 beats/min, WBC > 12,000 or < 4,000, or > 10% bands.

Measure: A composite endpoint of postoperative infectious complications at 90 days post-randomization: Infectious complications will include wound infections, pneumonia, and sepsis.

Time: 90 days after randomization

Description: The diagnosis of cardiac arrhythmias will be based on EKG findings. Only arrhythmias that result in initiation of new treatment regimen (to include medications, implantable devices, or surgical intervention) during hospitalization will be recorded. CHF will require at least one of the following symptoms or signs new or worsening: dyspnea at rest, orthopnea, or paroxysmal nocturnal dyspnea and radiological evidence of heart failure or worsening heart failure and increase/initiation of established treatment. Cardiac arrest will be defined as the cessation of cardiac pump function activity that results in loss of consciousness and absence of circulating blood flow as evidenced by absent carotid pulse. Only episodes of cardiac arrest that are reversed will be collected under this endpoint. If they are not reversed the event will be categorized as death.

Measure: A composite endpoint of cardiac complications (other than MI) at 90 days post-randomization: Cardiac complications will include new cardiac arrhythmias that necessitate new treatment, new or worsening congestive heart failure (CHF), and cardiac arrest no

Time: 90 days after randomization

Description: The investigators will determine vital status by telephoning participants after hospital discharge, by searching the electronic medical record and the National Death Index.

Measure: All-cause mortality at 1 year after randomization.

Time: 12 months after randomization

Description: MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.

Measure: A composite endpoint of all-cause mortality,

Time: 30 days after randomization

Description: Length of hospital stay

Measure: Length of hospital stay.

Time: At hospital discharge, up to 1 year

Other Outcomes

Description: All cause postoperative mortality, Postoperative MI, Postoperative coronary revascularization, Postoperative stroke,Postoperative acute renal failure

Measure: The investigators will examine individual rates of the outcomes that consist of individual components of the primary endpoint.

Time: 90 days after randomization
3 In-vivo Thrombus Imaging With 18F-GP1, a Novel Platelet PET Radiotracer

To date, the investigators have successfully employed a radiotracer (18F-sodium fluoride) as a marker of necrotic inflammation in human atherosclerosis. The investigators aim to further the mechanistic understanding of atherothrombosis by studying the activation of glycoprotein IIb/IIIa receptors in cardiovascular thrombus using the novel platelet radiotracer (18F-GP1). Binding of 18F-GP1 to activated platelets in venous and arterial thrombi has already been demonstrated in pre-clinical studies and a phase 1 trial in man. If successful, this study would define the role of the glycoprotein IIb/IIIa receptor within in vivo thrombosis across a range of cardiovascular diseases.

NCT03943966
Conditions
  1. Thrombosis
  2. Atherothrombosis
  3. Myocardial Infarction
  4. STEMI
  5. NSTEMI - Non-ST Segment Elevation MI
  6. DVT
  7. Pulmonary Embolism
  8. Stroke
  9. Transient Ischemic Attack
  10. Prosthetic Valve Thrombosis
  11. PET
Interventions
  1. Diagnostic Test: 18F-GP1 PET CT
MeSH:Pulmonary Embolism Ischemic Attack, Transient Myocardial Infarction Thrombosis Embolism Infarction
HPO:Myocardial infarction Pulmonary embolism Transient ischemic attack

Primary Outcomes

Description: Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation.

Measure: Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus compared with the SUVs recorded in the blood pool.

Time: 6 months from end of recruitment

Secondary Outcomes

Description: Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation in all 5 disease states

Measure: Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus formed in each of the 5 disease states.

Time: 6 months from end of recruitment
4 A Phase 2 Open Label Study to Assess the PK and PD Properties of a Single Subcutaneous Injection of RUC-4 in Patients With a ST-elevation Myocardial Infarction Presenting to the Cardiac Catheterization Lab With Planned Primary Coronary Angioplasty

RUC-4 is a novel, promising and fast acting (5-15 minutes) αIIbβ3 receptor antagonist with a high-grade inhibition of platelet aggregation (≥80%) shortly after subcutaneous administration. This study is designed to extend the findings in CEL-01 to patients with ST-elevation myocardial Infarction (STEMI) presenting to the cardiac catheterization laboratory with planned coronary angioplasty.

NCT04284995
Conditions
  1. Coronary Disease
  2. Myocardial Infarction
  3. Heart Diseases
  4. Vascular Diseases
  5. STEMI - ST Elevation Myocardial Infarction
Interventions
  1. Drug: RUC-4 Compound
MeSH:Myocardial Infarction Heart Diseases Vascular Diseases Coronary Disease ST Elevation Myocardial Infarction Infarction
HPO:Myocardial infarction

Primary Outcomes

Description: Inhibition of Platelet Aggregation

Measure: Platelet Inhibition

Time: Baseline

Description: Inhibition of Platelet aggregation

Measure: Platelet Inhibition

Time: 15 minutes

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 45 minutes

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 60 minutes

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 90 minutes

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 120 minutes

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 180 minutes

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: Baseline

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 15 minutes

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 45 minutes

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 90 minutes

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 120 minutes

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 180 minutes

Description: Bleeding events, Injection site reactions,vital signs, ECG, laboratory results

Measure: Safety and Tolerability

Time: Baseline

Description: Bleeding events, Injection site reactions,vital signs, ECG, laboratory results

Measure: Safety and Tolerability

Time: Hospital discharge

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 240 minutes

Description: Inhibition of platelet aggregation

Measure: Platelet aggregation

Time: 240 minutes
5 Cardiovascular Complications in Patients With COVID-19

Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

NCT04335162
Conditions
  1. COVID
  2. Acute Coronary Syndrome
  3. Myocardial Infarction
  4. Myocarditis
  5. Venous Thromboembolism
  6. Deep Vein Thrombosis
  7. Pulmonary Embolism
MeSH:Pulmonary Embolism Myocardial Infarction Thrombosis Acute Coronary Syndrome Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis Myocarditis
HPO:Deep venous thrombosis Myocardial infarction Myocarditis Pulmonary embolism Thromboembolism Venous thrombosis

Primary Outcomes

Description: Incidence of cardiomyopathies and/or venous thromboembolism at day 28

Measure: Determine the incidence of cardiomyopathies and venous thromboembolism

Time: 28 days

Secondary Outcomes

Description: Incidence of mortality at day 28

Measure: Mortality

Time: 28 days

Description: Number of day of using mechanical ventilation for each patients

Measure: Duration of mechanical ventilation

Time: hospitalisation duration

Description: Incidence of shock during hospitalisation

Measure: Shock

Time: hospitalisation duration

Description: Number of day at hospital

Measure: length of stay

Time: hospitalisation duration

Description: Setting up or not of mechanical ventilation

Measure: Mechanical ventilation

Time: hospitalisation duration

Description: Administration or not of renal replacement therapy

Measure: Renal replacement therapy

Time: hospitalisation duration
6 Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study

In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.

NCT04357314
Conditions
  1. Myocardial Infarction
MeSH:Myocardial Infarction Infarction
HPO:Myocardial infarction

Primary Outcomes

Description: Free wall rupture, acute ischemic mitral regurgitation, ventricular septal rupture

Measure: The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

Description: Compare the number of patients presenting to cardiology department with acute myocardial infarction in 2019 versus in 2020

Measure: Rates of patients presenting with acute myocardial infarction

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

Secondary Outcomes

Description: Correlation between clinical patient profile and the degree of affection of regions by COVID-19

Measure: Patient profile during admission for acute myocardial infarction

Time: 3 months (between March 1 to May 31

Description: Correlation between the delay between onset of symptoms - first medical contact - coronary angiography room and the degree of affection of regions by COVID-19

Measure: Medical care times analysis

Time: 3 months (between March 1 to May 31)

Description: Delay in minutes from symptom onset and STEMI (ST Segment Elevation Myocardial Infarction) diagnosis; and delay in minutes from onset of symptoms and primary PCI (percutaneous coronary intervention)

Measure: Medical care times analysis

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

Description: Correlation between the fate of patient and the degree of affection of regions by COVID-19: Number of days in cardiology department, Left Ventricular Ejection Fraction at discharge, presence of hemodynamic complications, presence of mechanical complications, transfer to intensive care unit, infection with COVID-19 during hospitalization, living status at discharge

Measure: Clinical evolution of patients

Time: 3 months (between March 1 to May 31)

Description: Number of in hospital outcomes including orotracheal intubation, cardiogenic shock, arrhythmias (ventricular tachycardia of ventricular fibrillation) and in hospital cardiac arrest

Measure: Clinical evolution of patients

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

Description: Number of patient admitted in cardiology department with STEMI (ST Segment Elevation Myocardial Infarction)

Measure: STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

Description: Correlation between the number of patients who underwent systemic thrombolysis and the degree of affection of regions by COVID-19

Measure: Proportion of patients who underwent systemic thrombolysis

Time: 3 months (between March 1 to May 31)

Description: Number of patient admitted in cardiology department for acute myocardial infarction infected with COVID-19

Measure: Proportion of patients infected with COVID-19

Time: 3 months (between March 1 to May 31)
7 Acute Cardiovascular Events Triggered by COVID-19-Related, Non-infectious Stress The Jordan COVID-9 caRdiovascular Events (JoCORE) Study

The current COVID19 pandemic has afflicted almost the whole globe. The stress related to the pandemic, not the direct virus-related injury, can be potentially associated with acute cardiovascular events due to a large list of physical and psychosocial stresses. This study is a cross sectional study that will enroll patients evaluated during the COVID19 pandemic period for acute cardiovascular events.

NCT04368637
Conditions
  1. Acute Myocardial Infarction
  2. Ventricular Tachycardia
  3. Sudden Cardiac Death
  4. Stroke, Acute
MeSH:Stroke Myocardial Infarction Tachycardia Tachycardia, Ventricular Death, Sudden, Cardiac Infarction Death
HPO:Myocardial infarction Stroke Sudden cardiac death Tachycardia Ventricular tachycardia

Primary Outcomes

Description: Acute myocardial infarction as diagnosed by ST segment elevation or depression or inverted T wave on 12-lead EKG and elevated levels of cardiac troponins above the 99% of the normal values. A. Acute MI (STEMI and NSTEMI). B. Aborted on non-aborted sudden cardiac death not attributed to a known etiology. C. Sustained or non-sustained ventricular tachy-arrhythmia not attributed to a known etiology. D. ICD shocks. 3. Absence of suspected or confirmed infection with the COVID19 virus. 4. Definite physical or psycho-social stressful trigger appearing in relation to the COVID-19 situation (lock down stress, financial stress, anger, depression, fear, sorrow, death of a significant person, eating binges, smoking binges, physical stress [carrying walking for shopping and carrying excess weights] ..etc) as judged by a unanimous agreement of three investigators in the steering committee.

Measure: Acute cardiovascular event triggered by COVID-19 stress

Time: 4 months

Description: Typical ventricular tachycardia on 12-lead EKG or EKG monitor.

Measure: Ventricular tachycardia

Time: 4 months

Description: acute neurological symptoms of hemiparesis or dysrthria due to brain ischemia proven by computerized tomography or magnatic resonance

Measure: acute stroke

Time: 4 months

Description: Finding an episode of ventricular tachycardia on interrogation of ICD tracing

Measure: Implantable cardioverter defibrillator (ICD) shock

Time: 4 months
8 International Study on Acute Coronary Syndromes - ST-segment Elevation Myocardial Infarction COVID 19

The ISACS STEMI COVID-19 has been established in response to the emerging outbreak of COVID-19 to provide a European overview to estimate the real impact of COVID-19 pandemic on treatment and outcome of STEMI by primary angioplasty, and to identify any potential category of patients at risk for delay to treatment or no presentation.

NCT04412655
Conditions
  1. ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion
Interventions
  1. Device: Percutaneous Coronary Revascularization for STEMI
MeSH:Myocardial Infarction ST Elevation Myocardial Infarction Infarction
HPO:Myocardial infarction

Primary Outcomes

Description: Number of patients undergoing primary angioplasty

Measure: Number of patients undergoing primary angioplasty

Time: March April 2019 and 2020

Description: Number of patients undergoing primary angioplasty later 12 hours from symptoms onset;

Measure: Number of patients undergoing primary angioplasty later than 12 hours from symptoms onset;

Time: March April 2019 and 2020

Description: Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission

Measure: Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission

Time: March April 2019 and 2020

Description: In-Hospital mortality

Measure: In-hospital mortality

Time: March April 2019 and 2020
9 MYocardial DOmmages Related to COVID-19

Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation of cardiac biomarkers could be linked to the occurrence of myocarditis.

NCT04498065
Conditions
  1. Covid19
  2. Non Ischemic Myocardial Injury
  3. Myocardial Infarction
  4. Myocarditis
  5. Troponin Elevation
Interventions
  1. Biological: Biological data
  2. Other: Clinical data
MeSH:Myocardial Infarction Myocarditis Infarction
HPO:Myocardial infarction Myocarditis

Primary Outcomes

Description: Myocardtitis diagnosis in patients COVID+ and troponin+

Measure: characterize the myocardial damage associated with CoV-2 SARS infection

Time: Through study completion, an average of 1 year
10 EPIdemiological Approaches to the Cardiovascular Consequences of COVID-19

The COVID-19 pandemic highlights the importance of the prognosis of co-morbidities, such as coronary artery disease, which significantly increase the risk of mortality in patients infected with SARS-CoV2. Investigators have recently studied the complex links between respiratory infections, particularly pneumonia, and type 2 myocardial infarction (MI) in many respects. The etiology of type 2 MI is based on an imbalance of myocardial oxygen supply/need in the absence of rupture/erosion of atheromatous plaques. Based on the RICO survey data, the investigators investigated whether COVID-19-related sepsis and/or respiratory failure could be an underlying mechanism of MI2.

NCT04498091
Conditions
  1. Acute Myocardial Infarction
Interventions
  1. Biological: Biological data
  2. Other: Clinical data
MeSH:Myocardial Infarction Infarction
HPO:Myocardial infarction

Primary Outcomes

Measure: Characterizing type 2 myocardial infarction associated with CoV-2 SARS infection

Time: Through study completion, an average of 1 year
11 COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications (CORONA-VTE NETWORK)

Novel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population.

NCT04535128
Conditions
  1. Covid19
  2. Thrombosis Embolism
  3. DVT
  4. Pulmonary Embolism
  5. Myocardial Infarction
  6. Stroke
Interventions
  1. Other: No intervention
MeSH:Pulmonary Embolism Myocardial Infarction Thrombosis Embolism Embolism and Thrombosis Infarction
HPO:Myocardial infarction Pulmonary embolism Thromboembolism

Primary Outcomes

Description: Frequency (%) of arterial or venous thromboembolism

Measure: Frequency of arterial or venous thromboembolism over 30 days

Time: 30 days

Description: Frequency (%) of arterial or venous thromboembolism

Measure: Frequency of arterial or venous thromboembolism over 90 days

Time: 90 days

Secondary Outcomes

Description: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes

Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days

Time: 30 days

Description: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes

Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days

Time: 90 days
12 Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France

The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care. Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.

NCT04542083
Conditions
  1. COVID-19
  2. Acute Cardiovascular Condition
  3. Acute Neurovascular Condition
  4. Stroke
  5. Acute Myocardial Infarction
MeSH:Stroke Myocardial Infarction Infarction Disease
HPO:Myocardial infarction Stroke

Primary Outcomes

Description: Daily number of admissions for acute cardio- and neurivascular conditions in France.

Measure: Daily number of admissions for acute cardio- and neurivascular conditions in France.

Time: 1 day

Secondary Outcomes

Description: Specific mortality rate.

Measure: Specific mortality rate.

Time: 1 day
13 Abbott Vascular Medical Device Registry

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

NCT04573660
Conditions
  1. Critical Limb Ischemia
  2. Symptomatic Ischemic Heart Disease
  3. Acute Myocardial Infarction
  4. Restenoses, Coronary
  5. Coronary Artery Lesions
  6. Venous Embolism
  7. Arterial Embolism
Interventions
  1. Device: XIENCE PRIME BTK stent
  2. Device: Absolute Pro LL stent
  3. Device: Supera 7.5 OD stent
  4. Device: Xpert Pro stent
  5. Device: Pacel BPC
  6. Device: Pacel FDPC
  7. Device: AVP I
  8. Device: AVP II
  9. Device: AVP 4
  10. Device: PressureWire X
  11. Device: MULTI-LINK 8 stent
  12. Device: MULTI-LINK 8 LL stent
  13. Device: MULTI-LINK 8 SV stent
MeSH:Myocardial Infarction Heart Diseases Embolism Myocardial Ischemia Coronary Artery Disease Coronary Restenosis Infarction Ischemia
HPO:Coronary artery atherosclerosis Myocardial infarction

Primary Outcomes

Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: 30 days

Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: 12 months

Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: 30 days

Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: 12 months

Description: Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive AVP or AVP II or AVP 4 and its competitors.

Measure: Number of participants with composite of potential complications (Implant success, occlusion success,migration)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of occlusion success and migration will be assessed among the patients who receive AVP or AVP II or AVP 4 and its competitors.

Measure: Number of participants with composite of occlusion success and migration

Time: 30 days

Description: Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive PressureWire X and its competitors.

Measure: Number of participants with composite of vessel dissection, perforation, and thromboembolism

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03) will be assessed among the patients who receive PressureWire X and its competitors.

Measure: Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Loss of capture (average time of loss of capture across patients) will be assessed among the patients who receive Pacel FDPC and its competitors.

Measure: Loss of capture

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patientswho receive Pacel BPC and its competitors.

Measure: Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: 30 days

Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: 12 months
14 CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction

To compare myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR

NCT04628104
Conditions
  1. Myocardial Infarction
Interventions
  1. Radiation: cardiac magnetic resonance
MeSH:Myocardial Infarction Infarction
HPO:Myocardial infarction

Primary Outcomes

Description: Distribution and Extent of myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR.

Measure: comparison between COVID-19 and COVID-19 presented with myocardial infarction

Time: baseline
15 Cognitive Behavioral Therapy Following Myocardial Infarction

Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI.

NCT04649307
Conditions
  1. Myocardial Infarction
Interventions
  1. Behavioral: MI-CBT
MeSH:Myocardial Infarction Infarction
HPO:Myocardial infarction

Primary Outcomes

Description: Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

Measure: Cardiac anxiety questionnaire

Time: baseline

Description: Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

Measure: Cardiac anxiety questionnaire

Time: 2 months from baseline

Description: Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

Measure: Cardiac anxiety questionnaire

Time: 8 months from baseline

Secondary Outcomes

Description: General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

Measure: 12-Item Short-Form Health Survey (SF-12)

Time: Baseline

Description: General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

Measure: 12-Item Short-Form Health Survey (SF-12)

Time: 2 months from baseline

Description: General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

Measure: 12-Item Short-Form Health Survey (SF-12)

Time: 8 months from baseline

Description: Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

Measure: Body Sensation Questionnaire

Time: Baseline

Description: Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

Measure: Body Sensation Questionnaire

Time: 2 months from baseline

Description: Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

Measure: Body Sensation Questionnaire

Time: 8 months from baseline

Description: Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

Measure: Patient Health Questionnaire-9

Time: Baseline

Description: Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

Measure: Patient Health Questionnaire-9

Time: 2 months from Baseline

Description: Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

Measure: Patient Health Questionnaire-9

Time: 8 months from Baseline

Description: General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

Measure: Generalized Anxiety Disorder 7-item

Time: Baseline

Description: General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

Measure: Generalized Anxiety Disorder 7-item

Time: 2 months from baseline

Description: General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

Measure: Generalized Anxiety Disorder 7-item

Time: 8 months from baseline

Description: Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.

Measure: The Godin Leisure-time Exercise

Time: Baseline

Description: Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.

Measure: The Godin Leisure-time Exercise

Time: 2 months from Baseline

Description: Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.

Measure: The Godin Leisure-time Exercise

Time: 8 months from Baseline

Description: Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

Measure: Tampas Scale for Kinesophobia-Heart version

Time: Baseline

Description: Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

Measure: Tampas Scale for Kinesophobia-Heart version

Time: 2 months from Baseline

Description: Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

Measure: Tampas Scale for Kinesophobia-Heart version

Time: 8 months form Baseline

Description: Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.

Measure: Client satisfaction Questionnaire

Time: 2 months from Baseline

Description: Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').

Measure: Adverse events

Time: 2 months from baseline

Description: Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').

Measure: Adverse events

Time: 8 months from baseline
16 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Safety and Efficacy of Ad5FGF-4 in Patients With Refractory Angina Due to Myocardial Ischemia

The purpose of this study is to determine whether a single intracoronary infusion of an adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4 (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life. Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT) duration. Long-term safety of Ad5FGF-4 will also be assessed.

NCT02928094
Conditions
  1. Angina, Stable
Interventions
  1. Biological: Ad5FGF-4
  2. Biological: Placebo
MeSH:Angina Pectoris Myocardial Ischemia Coronary Artery Disease Angina, Stable Ischemia
HPO:Angina pectoris Coronary artery atherosclerosis Myocardial infarction

Primary Outcomes

Description: Modified Bruce Protocol with exercise duration limited by angina or angina equivalent

Measure: Change in Exercise Tolerance Test (ETT) duration

Time: Baseline and Month 6

Secondary Outcomes

Description: Canadian Cardiovascular Society (CCS) angina classification

Measure: Change in patient functional status (CCS class)

Time: Baseline and Month 6

Description: Average weekly angina episodes

Measure: Change in weekly angina frequency

Time: Baseline and Month 6

Description: Average weekly nitroglycerin usage

Measure: Change in weekly nitroglycerin usage

Time: Baseline and Month 6

Description: Seattle Angina Questionnaire

Measure: Change in quality of life

Time: Baseline and Month 6

Description: Adverse events and clinical laboratory testing

Measure: Safety of Ad5FGF-4

Time: Through Month 6

Description: Occurrence of clinically significant events

Measure: Long-term safety of Ad5FGF-4

Time: Through Month 60
17 Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease (The FAVOR III China Study)

The overall purpose of the FAVOR III China trial is to investigate if a strategy of quantitative flow ratio (QFR)-guided percutaneous coronary intervention (PCI) yields superior clinical outcome and cost-effectiveness compared to a strategy of standard coronary angiography-guided PCI in evaluation of patients with coronary artery disease.

NCT03656848
Conditions
  1. Coronary Artery Disease
  2. Myocardial Ischaemia
  3. Coronary Circulation
  4. Coronary Stenosis
  5. Percutaneous Coronary Intervention
Interventions
  1. Diagnostic Test: QFR
  2. Diagnostic Test: Angiography
MeSH:Coronary Artery Disease Myocardial Ischemia Coronary Disease Coronary Stenosis Ischemia
HPO:Coronary artery atherosclerosis Coronary artery stenosis Myocardial infarction

Primary Outcomes

Description: A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization

Measure: MACE

Time: 1 year

Secondary Outcomes

Description: all-cause mortality, any spontaneous myocardial infarction and any ischemia-driven revascularization

Measure: MACE excluding peri-procedural MI (Major secondary endpoint)

Time: 1 year

Description: Cardiovascular, non-cardiovascular and undetermined death

Measure: Death

Time: 1 month, 6 months, 1 year, 2 years and 3 years

Description: Target vessel related and non-target vessel related MI

Measure: MI

Time: 1 month, 6 months, 1 year, 2 years and 3 years

Description: The ischemia driven and non-ischemia driven TVR

Measure: Target vessel revascularization (TVR)

Time: 1 month, 6 months, 1 year, 2 years and 3 years

Description: The The ischemia driven and non-ischemia driven Revascularization

Measure: Any coronary artery revascularization

Time: 1 month, 6 months, 1 year, 2 years and 3 years

Description: Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase according to the Academic Research Consortium (ARC)-2

Measure: Definite or probable stent thrombosis

Time: 1 month, 6 months, 1 year, 2 years and 3 years

Description: PCI strategy changes following QFR and three-dimension quantitative coronary angiography (3D-QCA)

Measure: The PCI strategy changes based on the QFR and 3D-QCA

Time: During the procedure

Description: Costs include direct clinical costs during the initial hospitalization and other resources used, main cardiovascular medication expenses, and outpatient and/or hospitalization expenses associated with MACE.

Measure: Cost during 1-year follow-up

Time: 1 month, 6 months, 1 year

Description: QALYs determined using EuroQol five dimensions questionnaire (EQ-5D) in official Chinese version, to assess the quality of life.

Measure: Quality-adjusted-life-years (QALYs) index

Time: 1 month, 6 months, 1 year
18 A Randomized Controlled Trial to Reduce Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease

After a 30-year decline, heart disease is projected to increase up to 18% by 2030. Participation rates in cardiac rehabilitation remain extremely low and hopeless individuals are less likely to participate. This innovative study has the potential to advance science, improve patient care, and improve patient outcomes by demonstrating the effectiveness of the Heart Up! program to increase physical activity and reduce hopelessness in patients with heart disease. Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. While research has investigated strategies to increase PA among IHD patients in general, the study team is the only group to design an intervention to promote PA specifically in hopeless IHD patients. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. A total of 225 hopeless IHD patients will be enrolled from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). It is hypothesized that 1) The MSS with SOS group will have the greatest increase in average minutes of moderate to vigorous PA per day at 8 and 24 weeks as compared to the MSS only or AC groups; 2) Greater increase in minutes of moderate to vigorous PA per day will be associated with decreased state hopelessness levels from baseline to weeks 8 and 24; and 3) Increased social support and increased motivation will mediate the effects of Heart Up! on a greater increase in moderate to vigorous PA at 8 and 24 weeks. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes.

NCT03907891
Conditions
  1. Ischemic Heart Disease
  2. Hopelessness
  3. Physical Activity
  4. Motivation
  5. Social Support
  6. Covid19
Interventions
  1. Behavioral: Motivational social support from nurse
  2. Behavioral: Motivational social support from nurse with additional support from significant other
  3. Behavioral: Attention control
MeSH:Heart Diseases Myocardial Ischemia Coronary Artery Disease Ischemia
HPO:Coronary artery atherosclerosis Myocardial infarction

Primary Outcomes

Description: Mean minutes/day moderate to vigorous physical activity

Measure: ActiGraph GT9X Link Accelerometer

Time: Month 12

Description: Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse).

Measure: State-Trait Hopelessness Scale

Time: Month 12

Secondary Outcomes

Description: Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better).

Measure: Exercise Self-Regulation Questionnaire

Time: Month 12

Description: Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better).

Measure: ENRICHD Social Support Inventory

Time: Month 12

Other Outcomes

Description: Comorbidity score based on medical record abstraction. Total score range= 0 (better) to 100 (worse).

Measure: Charlson Comorbidity Index

Time: Week 1

Description: Participant's report of participation level with exercise in home, community or cardiac rehabilitation program

Measure: Cardiac Rehabilitation Exercise Participation Tool

Time: Month 12

Description: Participant's report of mean level of depressive symptoms. Total score range= 0 (better) to 27 (worse).

Measure: Patient Health Questionnaire-9

Time: Month 12

Description: Participant's report of mean level of well-being. Total score range= 4 (better) to 20 (worse).

Measure: PROMIS-29

Time: Month 12

Description: Participant's report of mean level state and trait hope. Total score range= 8 (worse) to 64 (better).

Measure: Snyder State Trait Scales

Time: Month 12

Description: Participant's report of mean level of quality of life. Total score range= 1 (better) to 5 (worse).

Measure: EuroQol (EQ-5d-5L)

Time: Month 12

Description: Participant's report of COVID-19 symptoms, diagnosis, testing, and social distancing. No score range (14 items).

Measure: Multi-Ethnic Study of Atherosclerosis (MESA) COVID-19 Questionnaire

Time: Month 12

Description: Participant's report of impact on routine; income/ employment; access to food, medical and mental health care, extended family; and stress. No range (12 items)

Measure: Coronavirus Impact Scale

Time: Month 12
19 Integrated Distance Management Strategy for Patients With Cardiovascular Disease (Ischaemic Coronary Artery Disease, High Blood Pressure, Heart Failure) in the Context of the COVID-19 Pandemic

Management of known patients with cardiovascular disease (in particular the whole spectrum of atherosclerotic ischaemic coronary artery disease, essential hypertension under treatment, and also patients with chronic heart failure under medication) and with other associated chronic pathologies, with obvious effects on the management of the pandemic with modern / distance means (e-Health) of patients at high risk of mortality in contact with coronavirus. Given the Covid-19 Pandemic, all the above complex cardiovascular patients are under the obligation to stay in the house isolated and can no longer come to standard clinical and paraclinical monitoring and control visits. Therefore, a remote management solution (tele-medicine) of these patients must be found. The Investigators endeavour is to create an electronic platform to communicate with these patients and offer solutions for their cardiovascular health issues (including psychological and religious problems due to isolation). The Investigators intend to create this platform for communicating with a patient and stratify their complaints in risk levels. A given specialist will sort and classify their needs on a scale, based on specific algorithms (derived from the clinical European Cardiovascular Guidelines), and generate specific protocols varying from 911 like emergencies to cardiological advices or psychological sessions. These could include medication changing of doses, dietary advices or exercise restrictions. Moreover, in those patients suspected of COVID infection, special assistance should be provided per protocol.

NCT04325867
Conditions
  1. Angina Pectoris
  2. Acute Coronary Syndrome
  3. Coronary Syndrome
  4. Coronary Artery Disease
  5. Angioplasty
  6. Stent Restenosis
  7. Hypertension
  8. Heart Failure, Systolic
  9. Depression, Anxiety
  10. Covid-19
  11. Isolation, Social
Interventions
  1. Other: Tele-medicine platform
MeSH:Heart Failure Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Angina Pectoris Heart Failure, Systolic Syndrome
HPO:Abnormal left ventricular function Abnormality of the cardiovascular system Angina pectoris Congestive heart failure Coronary artery atherosclerosis Myocardial infarction Right ventricular failure

Primary Outcomes

Description: Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context

Measure: Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients

Time: 6 months

Description: patients come into direct contact with the case coordinator, who provides ongoing assistance, including for connecting to devices that ensure real-time data transmission and directing to specialist teams that establish stage diagnosis and management / therapy behavior (including adjustment). doses, decisions to discontinue medication or to add medication);

Measure: Number of patients included in this platform

Time: 6 months

Secondary Outcomes

Description: Will be the number of sessions per patient multiplied with the number of patients included

Measure: Number of consultations/sessions given

Time: 6 months
20 Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses

Percutaneous cardiovascular intervention procedures (e.g. coronary angioplasty, peripheral artery angioplasty) must be performed in person, requiring the physical presence of one or more medical, nursing and technical professionals. The control of catheters and interventional materials is performed manually, with the operator positioned next to the patient. This context results in potential for reciprocal exposure to exhaled air, both for the professionals involved and for the patient, with an inherent risk of aerial contamination. It is important to note that interventional procedures are often performed on an urgent or emergency basis (e.g. myocardial infarction), without the possibility of postponement or postponement. The recent robot-assisted cardiovascular intervention makes it possible to modify this scenario by allowing the procedure to be performed effectively and safely in a position far from the patient. In an environment with high potential for contamination, mainly related to the current pandemic caused by the COVID-19 virus, may prove to be a tactic to expand hospital security. It is in this sense that the present pilot proposal is inserted, which, ultimately, aims to evaluate the potential of robotic intervention as a strategy to reduce exposure to exhaled air of patients and professionals during the intervention procedure.

NCT04379453
Conditions
  1. Coronary Artery Disease
Interventions
  1. Procedure: Robot Assisted Percutaneous Cardiovascular Intervention
MeSH:Coronary Artery Disease Myocardial Ischemia Coronary Disease
HPO:Coronary artery atherosclerosis Myocardial infarction

Primary Outcomes

Description: (arterial dilation with residual lesion <50% at angiography and normal anterograde flow)

Measure: Successful cardiovascular intervention

Time: Until the end of the procedure

Measure: Performed with the professional team positioned at> 2 meters from the patient for at least 50% of the duration of the intervention

Time: Until the end of the procedure

Measure: absence of fatal complications caused by the procedure or acute non-fatal vessel occlusion during index admission

Time: Until the end of the procedure
21 Infinity-Swedeheart Study: Registry Based Randomized Clinical Trial (R-RCT) Comparing Long Term Outcomes of the DynamX Bioadaptor to the Resolute Onyx Stent in a More-comer PCI Patient Population

The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx).

NCT04562805
Conditions
  1. Coronary Artery Disease
  2. Ischemic Heart Disease
Interventions
  1. Device: DynamX Bioadaptor
  2. Device: Resolute Onyx
MeSH:Coronary Artery Disease Myocardial Ischemia Heart Diseases
HPO:Coronary artery atherosclerosis Myocardial infarction

Primary Outcomes

Description: Device Oriented Clinical Endpoint (DOCE) of target lesion failure (TLF; cardiovascular death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR))

Measure: Target Lesion Failure (TLF)

Time: 1 year

Secondary Outcomes

Description: Lesion-Level Analysis

Measure: Device Success

Time: During Study Procedure

Description: Patient-Level Analysis

Measure: Procedural Success

Time: In-Hospital, assessed up to 7 days

Description: Composite Device Oriented Clinical Endpoint (DOCE) (TLF; cardiovascular death, TV-MI, ischemia-driven TLR)

Measure: Composite Rate of Device Oriented Clinical Endpoint (DOCE)

Time: 30 days, 6 months, 1-5 years

Description: Composite Patient Oriented Clinical Endpoint (POCE) (all-cause mortality, any stroke, any myocardial infarction (includes non-target vessel territory) and any revascularization). Note: Stroke to be collected and included in the POCE at 1 year and 5 years only.

Measure: Composite Rate of Patient Oriented Clinical Endpoint (POCE)

Time: 30 days, 6 months, 1-5 years

Description: Target vessel failure (TVF; cardiovascular death, target vessel myocardial infarction (TV-MI), or target vessel revascularization (TVR))

Measure: Rate of Target Vessel Failure (TVF)

Time: 30 days, 6 months, 1-5 years

Description: Composite of cardiovascular death, any myocardial infarction and any revascularization

Measure: Composite Rate of cardiovascular death, any myocardial infarction and any revascularization

Time: 30 days, 6 months, 1-5 years

Description: Ischemia driven target lesion revascularization (ID-TLR)

Measure: Rate of Ischemia driven target lesion revascularization (ID-TLR)

Time: 30 days, 6 months, 1-5 years

Description: All Target Lesion Revascularization

Measure: Rate of Target Lesion Revascularization (TLR)

Time: 30 days, 6 months, 1-5 years

Description: All Target Vessel Revascularization

Measure: Rate of Target Vessel Revascularization (TVR)

Time: 30 days, 6 months, 1-5 years

Description: Ischemia driven target vessel revascularization (ID-TVR)

Measure: Rate of Ischemia driven target vessel revascularization (ID-TVR)

Time: 30 days, 6 months, 1-5 years

Description: Ischemia driven non target vessel revascularization (ID-NTVR)

Measure: Rate of Ischemia driven non target vessel revascularization (ID-NTVR)

Time: 30 days, 6 months, 1-5 years

Description: Non target vessel revascularization (NTVR)

Measure: Rate of Non target vessel revascularization (NTVR)

Time: 30 days, 6 months, 1-5 years

Description: All revascularization

Measure: Rate of All revascularization

Time: 30 days, 6 months, 1-5 years

Description: All MI, Q-Wave and Non Q-Wave MI, TV-MI, NTV-MI

Measure: Rate of Myocardial Infarction

Time: 30 days, 6 months, 1-5 years

Description: Cardiovascular Death, All-Cause Death

Measure: Rate of Death

Time: 30 days, 6 months, 1-5 years

Description: Composite: Cardiovascular death or myocardial infarction

Measure: Composite: Cardiovascular death or myocardial infarction

Time: 30 days, 6 months, 1-5 years

Description: Composite: All-cause death or myocardial infarction

Measure: Composite: All-cause death or myocardial infarction

Time: 30 days, 6 months, 1-5 years

Description: Composite: All-cause death, myocardial infarction or target vessel revascularization

Measure: Composite: All-cause death, myocardial infarction or target vessel revascularization

Time: 30 days, 6 months, 1-5 years

Description: Any stroke (collected at 1 year and 5 years only)

Measure: Rate of any stroke

Time: 1 year and 5 years

Description: Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)

Measure: Anginal Status

Time: 30 days and 1 year

Description: Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis

Measure: Rate of Stent Thrombosis

Time: 30 days, 6 months, 1-5 years
22 Abbott Vascular Medical Device Registry

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

NCT04573660
Conditions
  1. Critical Limb Ischemia
  2. Symptomatic Ischemic Heart Disease
  3. Acute Myocardial Infarction
  4. Restenoses, Coronary
  5. Coronary Artery Lesions
  6. Venous Embolism
  7. Arterial Embolism
Interventions
  1. Device: XIENCE PRIME BTK stent
  2. Device: Absolute Pro LL stent
  3. Device: Supera 7.5 OD stent
  4. Device: Xpert Pro stent
  5. Device: Pacel BPC
  6. Device: Pacel FDPC
  7. Device: AVP I
  8. Device: AVP II
  9. Device: AVP 4
  10. Device: PressureWire X
  11. Device: MULTI-LINK 8 stent
  12. Device: MULTI-LINK 8 LL stent
  13. Device: MULTI-LINK 8 SV stent
MeSH:Myocardial Infarction Heart Diseases Embolism Myocardial Ischemia Coronary Artery Disease Coronary Restenosis Infarction Ischemia
HPO:Coronary artery atherosclerosis Myocardial infarction

Primary Outcomes

Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: 30 days

Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: 12 months

Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: 30 days

Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: 12 months

Description: Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive AVP or AVP II or AVP 4 and its competitors.

Measure: Number of participants with composite of potential complications (Implant success, occlusion success,migration)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of occlusion success and migration will be assessed among the patients who receive AVP or AVP II or AVP 4 and its competitors.

Measure: Number of participants with composite of occlusion success and migration

Time: 30 days

Description: Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive PressureWire X and its competitors.

Measure: Number of participants with composite of vessel dissection, perforation, and thromboembolism

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03) will be assessed among the patients who receive PressureWire X and its competitors.

Measure: Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Loss of capture (average time of loss of capture across patients) will be assessed among the patients who receive Pacel FDPC and its competitors.

Measure: Loss of capture

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patientswho receive Pacel BPC and its competitors.

Measure: Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: 30 days

Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: 12 months

HPO Nodes


Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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706 reports on MeSH terms

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