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Sections: Correlations,
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Name (Synonyms) | Correlation | |
---|---|---|
drug564 | Biological data Wiki | 0.32 |
drug933 | Clinical data Wiki | 0.26 |
drug3390 | Robot Assisted Percutaneous Cardiovascular Intervention Wiki | 0.22 |
Name (Synonyms) | Correlation | |
---|---|---|
drug3080 | PressureWire X Wiki | 0.22 |
drug2860 | Percutaneous Coronary Revascularization for STEMI Wiki | 0.22 |
drug3342 | Resolute Onyx Wiki | 0.22 |
drug3805 | Supera 7.5 OD stent Wiki | 0.22 |
drug1870 | ISIS 721744 Wiki | 0.22 |
drug288 | Angiography Wiki | 0.22 |
drug215 | Ad5FGF-4 Wiki | 0.22 |
drug2803 | Pacel BPC Wiki | 0.22 |
drug3250 | RUC-4 Compound Wiki | 0.22 |
drug1872 | IV Dexamethasone Wiki | 0.22 |
drug2804 | Pacel FDPC Wiki | 0.22 |
drug2258 | MULTI-LINK 8 LL stent Wiki | 0.22 |
drug4494 | further processing of health data Wiki | 0.22 |
drug2437 | Motivational social support from nurse with additional support from significant other Wiki | 0.22 |
drug33 | 18F-GP1 PET CT Wiki | 0.22 |
drug1882 | Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki | 0.22 |
drug31 | 18F-DX600 PET/CT Wiki | 0.22 |
drug1883 | IgG Wiki | 0.22 |
drug2436 | Motivational social support from nurse Wiki | 0.22 |
drug2501 | Nasal Dexamethasone Wiki | 0.22 |
drug158 | AVP 4 Wiki | 0.22 |
drug396 | Attention control Wiki | 0.22 |
drug4322 | Xpert Pro stent Wiki | 0.22 |
drug185 | Absolute Pro LL stent Wiki | 0.22 |
drug54 | 3 Wishes Project Wiki | 0.22 |
drug26 | 12 weeks of bicycle exercise Wiki | 0.22 |
drug3918 | Tele-medicine platform Wiki | 0.22 |
drug592 | Blood Transfusion Wiki | 0.22 |
drug1881 | Icosapent ethyl (IPE) Wiki | 0.22 |
drug1291 | DynamX Bioadaptor Wiki | 0.22 |
drug3165 | QFR Wiki | 0.22 |
drug2259 | MULTI-LINK 8 SV stent Wiki | 0.22 |
drug159 | AVP I Wiki | 0.22 |
drug160 | AVP II Wiki | 0.22 |
drug4319 | XIENCE PRIME BTK stent Wiki | 0.22 |
drug2260 | MULTI-LINK 8 stent Wiki | 0.22 |
drug69 | 50 mg/mL Virazole Wiki | 0.16 |
drug1880 | Icosapent ethyl Wiki | 0.16 |
drug24 | 100 mg/mL Virazole Wiki | 0.16 |
drug2616 | Normal Saline Wiki | 0.09 |
drug514 | Baricitinib Wiki | 0.08 |
drug2575 | No intervention Wiki | 0.05 |
drug3192 | Questionnaire Wiki | 0.04 |
drug2916 | Placebo Wiki | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
D009203 | Myocardial Ischemia NIH | 0.95 |
D007238 | Infarction NIH | 0.74 |
D003324 | Coronary Artery Disease NIH | 0.52 |
Name (Synonyms) | Correlation | |
---|---|---|
D003327 | Coronary Disease NIH | 0.42 |
D002546 | Ischemic Attack, Transient NIH | 0.32 |
D000787 | Angina Pectoris NIH | 0.32 |
D007511 | Ischemia NIH | 0.32 |
D054143 | Heart Failure, Systolic NIH | 0.32 |
D013610 | Tachycardia NIH | 0.32 |
D006331 | Heart Diseases NIH | 0.30 |
D054058 | Acute Coronary Syndrome NIH | 0.27 |
D000072657 | ST Elevation Myocardial Infarction NIH | 0.26 |
D002561 | Cerebrovascular Disorders NIH | 0.22 |
D019462 | Syncope, Vasovagal NIH | 0.22 |
D013575 | Syncope NIH | 0.22 |
D054144 | Heart Failure, Diastolic NIH | 0.22 |
D016757 | Death, Sudden, Cardiac NIH | 0.22 |
D013616 | Tachycardia, Sinus NIH | 0.22 |
D017180 | Tachycardia, Ventricular NIH | 0.22 |
D023921 | Coronary Stenosis NIH | 0.22 |
D023903 | Coronary Restenosis NIH | 0.22 |
D060050 | Angina, Stable NIH | 0.22 |
D004617 | Embolism NIH | 0.21 |
D011655 | Pulmonary Embolism NIH | 0.17 |
D007022 | Hypotension NIH | 0.16 |
D009205 | Myocarditis NIH | 0.15 |
D013927 | Thrombosis NIH | 0.13 |
D015673 | Fatigue Syndrome, Chronic NIH | 0.13 |
D006333 | Heart Failure NIH | 0.13 |
D003643 | Death, NIH | 0.11 |
D001281 | Atrial Fibrillation NIH | 0.11 |
D014652 | Vascular Diseases NIH | 0.11 |
D020521 | Stroke NIH | 0.11 |
D016584 | Panic Disorder NIH | 0.11 |
D016769 | Embolism and Thrombosis NIH | 0.11 |
D005356 | Fibromyalgia NIH | 0.10 |
D054556 | Venous Thromboembolism NIH | 0.08 |
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 | 0.04 |
D004194 | Disease NIH | 0.04 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0001677 | Coronary artery atherosclerosis HPO | 0.52 |
HP:0001649 | Tachycardia HPO | 0.32 |
HP:0002326 | Transient ischemic attack HPO | 0.32 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0001681 | Angina pectoris HPO | 0.32 |
HP:0011703 | Sinus tachycardia HPO | 0.22 |
HP:0005145 | Coronary artery stenosis HPO | 0.22 |
HP:0012668 | Vasovagal syncope HPO | 0.22 |
HP:0001279 | Syncope HPO | 0.22 |
HP:0004756 | Ventricular tachycardia HPO | 0.22 |
HP:0001645 | Sudden cardiac death HPO | 0.22 |
HP:0002204 | Pulmonary embolism HPO | 0.17 |
HP:0002615 | Hypotension HPO | 0.16 |
HP:0012819 | Myocarditis HPO | 0.15 |
HP:0001635 | Congestive heart failure HPO | 0.13 |
HP:0001297 | Stroke HPO | 0.11 |
HP:0004757 | Paroxysmal atrial fibrillation HPO | 0.11 |
HP:0001907 | Thromboembolism HPO | 0.10 |
HP:0002625 | Deep venous thrombosis HPO | 0.06 |
HP:0001919 | Acute kidney injury HPO | 0.04 |
HP:0001626 | Abnormality of the cardiovascular system HPO | 0.04 |
Navigate: Correlations HPO
There are 20 clinical trials
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.
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 studyDescription: 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 studyDescription: 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 studyDescription: 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 studyDescription: 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 studyDescription: 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 studyDescription: 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 studyDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 studyDescription: 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 weeksDescription: 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 yearsDescription: 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 yearDescription: 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 yearsDescription: 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 yearsThe 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.
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 6Description: Canadian Cardiovascular Society (CCS) angina classification
Measure: Change in patient functional status (CCS class) Time: Baseline and Month 6Description: Average weekly angina episodes
Measure: Change in weekly angina frequency Time: Baseline and Month 6Description: Average weekly nitroglycerin usage
Measure: Change in weekly nitroglycerin usage Time: Baseline and Month 6Description: Seattle Angina Questionnaire
Measure: Change in quality of life Time: Baseline and Month 6Description: Adverse events and clinical laboratory testing
Measure: Safety of Ad5FGF-4 Time: Through Month 6Description: Occurrence of clinically significant events
Measure: Long-term safety of Ad5FGF-4 Time: Through Month 60The 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).
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 randomizationDescription: 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 randomizationDescription: 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 randomizationDescription: 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 randomizationDescription: MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.
Measure: A composite endpoint of all-cause mortality, Time: 30 days after randomizationDescription: Length of hospital stay
Measure: Length of hospital stay. Time: At hospital discharge, up to 1 yearDescription: 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 randomizationThe 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.
Description: A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization
Measure: MACE Time: 1 yearDescription: all-cause mortality, any spontaneous myocardial infarction and any ischemia-driven revascularization
Measure: MACE excluding peri-procedural MI (Major secondary endpoint) Time: 1 yearDescription: Cardiovascular, non-cardiovascular and undetermined death
Measure: Death Time: 1 month, 6 months, 1 year, 2 years and 3 yearsDescription: Target vessel related and non-target vessel related MI
Measure: MI Time: 1 month, 6 months, 1 year, 2 years and 3 yearsDescription: The ischemia driven and non-ischemia driven TVR
Measure: Target vessel revascularization (TVR) Time: 1 month, 6 months, 1 year, 2 years and 3 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 procedureDescription: 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 yearDescription: 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 yearAfter 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.
Description: Mean minutes/day moderate to vigorous physical activity
Measure: ActiGraph GT9X Link Accelerometer Time: Month 12Description: Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse).
Measure: State-Trait Hopelessness Scale Time: Month 12Description: Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better).
Measure: Exercise Self-Regulation Questionnaire Time: Month 12Description: Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better).
Measure: ENRICHD Social Support Inventory Time: Month 12Description: Comorbidity score based on medical record abstraction. Total score range= 0 (better) to 100 (worse).
Measure: Charlson Comorbidity Index Time: Week 1Description: Participant's report of participation level with exercise in home, community or cardiac rehabilitation program
Measure: Cardiac Rehabilitation Exercise Participation Tool Time: Month 12Description: Participant's report of mean level of depressive symptoms. Total score range= 0 (better) to 27 (worse).
Measure: Patient Health Questionnaire-9 Time: Month 12Description: Participant's report of mean level of well-being. Total score range= 4 (better) to 20 (worse).
Measure: PROMIS-29 Time: Month 12Description: 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 12Description: 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 12Description: 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 12Description: 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 12To 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.
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 recruitmentDescription: 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 recruitmentRUC-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.
Description: Inhibition of Platelet Aggregation
Measure: Platelet Inhibition Time: BaselineDescription: Inhibition of Platelet aggregation
Measure: Platelet Inhibition Time: 15 minutesDescription: Inhibition of Platelet aggregation
Measure: Platelet inhibition Time: 45 minutesDescription: Inhibition of Platelet aggregation
Measure: Platelet inhibition Time: 60 minutesDescription: Inhibition of Platelet aggregation
Measure: Platelet inhibition Time: 90 minutesDescription: Inhibition of Platelet aggregation
Measure: Platelet inhibition Time: 120 minutesDescription: Inhibition of Platelet aggregation
Measure: Platelet inhibition Time: 180 minutesDescription: concentration in blood (ng/mL)
Measure: RUC-4 Concentration Time: BaselineDescription: concentration in blood (ng/mL)
Measure: RUC-4 Concentration Time: 15 minutesDescription: concentration in blood (ng/mL)
Measure: RUC-4 Concentration Time: 45 minutesDescription: concentration in blood (ng/mL)
Measure: RUC-4 Concentration Time: 90 minutesDescription: concentration in blood (ng/mL)
Measure: RUC-4 Concentration Time: 120 minutesDescription: concentration in blood (ng/mL)
Measure: RUC-4 Concentration Time: 180 minutesDescription: Bleeding events, Injection site reactions,vital signs, ECG, laboratory results
Measure: Safety and Tolerability Time: BaselineDescription: Bleeding events, Injection site reactions,vital signs, ECG, laboratory results
Measure: Safety and Tolerability Time: Hospital dischargeDescription: concentration in blood (ng/mL)
Measure: RUC-4 Concentration Time: 240 minutesDescription: Inhibition of platelet aggregation
Measure: Platelet aggregation Time: 240 minutesManagement 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.
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 monthsDescription: 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 monthsDescription: Will be the number of sessions per patient multiplied with the number of patients included
Measure: Number of consultations/sessions given Time: 6 monthsPatients 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.
Description: Incidence of cardiomyopathies and/or venous thromboembolism at day 28
Measure: Determine the incidence of cardiomyopathies and venous thromboembolism Time: 28 daysDescription: Incidence of mortality at day 28
Measure: Mortality Time: 28 daysDescription: Number of day of using mechanical ventilation for each patients
Measure: Duration of mechanical ventilation Time: 28 daysDescription: Incidence of shock at day 28
Measure: shock at day 28 Time: 28 daysDescription: Number of day in intensive care unit
Measure: length of stay in the intensive care unit Time: 28 daysIn 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.
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 )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 31Description: 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)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.
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 monthsDescription: Typical ventricular tachycardia on 12-lead EKG or EKG monitor.
Measure: Ventricular tachycardia Time: 4 monthsDescription: acute neurological symptoms of hemiparesis or dysrthria due to brain ischemia proven by computerized tomography or magnatic resonance
Measure: acute stroke Time: 4 monthsDescription: Finding an episode of ventricular tachycardia on interrogation of ICD tracing
Measure: Implantable cardioverter defibrillator (ICD) shock Time: 4 monthsPercutaneous 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.
Description: (arterial dilation with residual lesion <50% at angiography and normal anterograde flow)
Measure: Successful cardiovascular intervention Time: Until the end of the procedureThe 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.
Description: Number of patients undergoing primary angioplasty
Measure: Number of patients undergoing primary angioplasty Time: March April 2019 and 2020Description: 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 2020Description: 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 2020Description: In-Hospital mortality
Measure: In-hospital mortality Time: March April 2019 and 2020Myocardial 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.
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 yearThe 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.
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.
Description: Frequency (%) of arterial or venous thromboembolism
Measure: Frequency of arterial or venous thromboembolism over 30 days Time: 30 daysDescription: Frequency (%) of arterial or venous thromboembolism
Measure: Frequency of arterial or venous thromboembolism over 90 days Time: 90 daysDescription: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes
Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days Time: 30 daysDescription: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes
Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days Time: 90 daysThe 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.
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 dayDescription: Specific mortality rate.
Measure: Specific mortality rate. Time: 1 dayThe 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).
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 yearDescription: Lesion-Level Analysis
Measure: Device Success Time: During Study ProcedureDescription: Patient-Level Analysis
Measure: Procedural Success Time: In-Hospital, assessed up to 7 daysDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: Ischemia driven target lesion revascularization (ID-TLR)
Measure: Rate of Ischemia driven target lesion revascularization (ID-TLR) Time: 30 days, 6 months, 1-5 yearsDescription: All Target Lesion Revascularization
Measure: Rate of Target Lesion Revascularization (TLR) Time: 30 days, 6 months, 1-5 yearsDescription: All Target Vessel Revascularization
Measure: Rate of Target Vessel Revascularization (TVR) Time: 30 days, 6 months, 1-5 yearsDescription: Ischemia driven target vessel revascularization (ID-TVR)
Measure: Rate of Ischemia driven target vessel revascularization (ID-TVR) Time: 30 days, 6 months, 1-5 yearsDescription: 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 yearsDescription: Non target vessel revascularization (NTVR)
Measure: Rate of Non target vessel revascularization (NTVR) Time: 30 days, 6 months, 1-5 yearsDescription: All revascularization
Measure: Rate of All revascularization Time: 30 days, 6 months, 1-5 yearsDescription: 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 yearsDescription: Cardiovascular Death, All-Cause Death
Measure: Rate of Death Time: 30 days, 6 months, 1-5 yearsDescription: Composite: Cardiovascular death or myocardial infarction
Measure: Composite: Cardiovascular death or myocardial infarction Time: 30 days, 6 months, 1-5 yearsDescription: Composite: All-cause death or myocardial infarction
Measure: Composite: All-cause death or myocardial infarction Time: 30 days, 6 months, 1-5 yearsDescription: 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 yearsDescription: Any stroke (collected at 1 year and 5 years only)
Measure: Rate of any stroke Time: 1 year and 5 yearsDescription: Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)
Measure: Anginal Status Time: 30 days and 1 yearDescription: Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis
Measure: Rate of Stent Thrombosis Time: 30 days, 6 months, 1-5 yearsThe 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.
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 daysDescription: 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 monthsDescription: 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 daysDescription: 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 monthsDescription: Composite of potential complications including implant success,occlusion success, migration will be assessed among the patients whoreceive 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 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 (minimal pressure drift > 3 mmHg) will be assessed among the patients who receive PressureWire X and its competitors.
Measure: Number of participants with signal drift (minimal pressure drift > 3 mmHg) 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, pulmonaryemboli, 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, pulmonaryemboli, 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 daysDescription: 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 monthsThe 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.
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 daysDescription: 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 monthsDescription: 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 daysDescription: 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 monthsDescription: Composite of potential complications including implant success,occlusion success, migration will be assessed among the patients whoreceive 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 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 (minimal pressure drift > 3 mmHg) will be assessed among the patients who receive PressureWire X and its competitors.
Measure: Number of participants with signal drift (minimal pressure drift > 3 mmHg) 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, pulmonaryemboli, 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, pulmonaryemboli, 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 daysDescription: 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 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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.
Drug Reports MeSH Reports HPO Reports