Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1215 | Dietary Intervention Wiki | 0.27 |
| drug3080 | PressureWire X Wiki | 0.27 |
| drug3342 | Resolute Onyx Wiki | 0.27 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3805 | Supera 7.5 OD stent Wiki | 0.27 |
| drug2803 | Pacel BPC Wiki | 0.27 |
| drug3250 | RUC-4 Compound Wiki | 0.27 |
| drug1872 | IV Dexamethasone Wiki | 0.27 |
| drug2804 | Pacel FDPC Wiki | 0.27 |
| drug2258 | MULTI-LINK 8 LL stent Wiki | 0.27 |
| drug3498 | STC-19 score Wiki | 0.27 |
| drug4617 | non-interventional Wiki | 0.27 |
| drug2437 | Motivational social support from nurse with additional support from significant other Wiki | 0.27 |
| drug1882 | Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki | 0.27 |
| drug1883 | IgG Wiki | 0.27 |
| drug2436 | Motivational social support from nurse Wiki | 0.27 |
| drug2501 | Nasal Dexamethasone Wiki | 0.27 |
| drug158 | AVP 4 Wiki | 0.27 |
| drug396 | Attention control Wiki | 0.27 |
| drug1884 | IgG SARS CoV 2 antibodies Wiki | 0.27 |
| drug3815 | Supraflex Cruz 60 Micron Wiki | 0.27 |
| drug4322 | Xpert Pro stent Wiki | 0.27 |
| drug185 | Absolute Pro LL stent Wiki | 0.27 |
| drug3328 | Remote Photoplethysmography (rPPG) vital sign acquisition Wiki | 0.27 |
| drug1881 | Icosapent ethyl (IPE) Wiki | 0.27 |
| drug1291 | DynamX Bioadaptor Wiki | 0.27 |
| drug4132 | Ultimaster Tansei 80 Micron Wiki | 0.27 |
| drug2259 | MULTI-LINK 8 SV stent Wiki | 0.27 |
| drug159 | AVP I Wiki | 0.27 |
| drug160 | AVP II Wiki | 0.27 |
| drug4319 | XIENCE PRIME BTK stent Wiki | 0.27 |
| drug735 | COVID visitation restrictions Wiki | 0.27 |
| drug2260 | MULTI-LINK 8 stent Wiki | 0.27 |
| drug69 | 50 mg/mL Virazole Wiki | 0.19 |
| drug1398 | Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki | 0.19 |
| drug1052 | Convalescent Plasma Transfusion Wiki | 0.19 |
| drug24 | 100 mg/mL Virazole Wiki | 0.19 |
| drug455 | BCG vaccine Wiki | 0.15 |
| drug1959 | Interferon Beta-1A Wiki | 0.13 |
| drug1127 | DAS181 Wiki | 0.11 |
| drug1396 | Enoxaparin Wiki | 0.07 |
| drug2029 | Ivermectin Wiki | 0.06 |
| drug1060 | Convalescent plasma Wiki | 0.06 |
| drug3192 | Questionnaire Wiki | 0.05 |
| drug1775 | Hydroxychloroquine Wiki | 0.03 |
| drug2916 | Placebo Wiki | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003327 | Coronary Disease NIH | 0.40 |
| D006330 | Heart Defects, Congenital NIH | 0.31 |
| D009203 | Myocardial Ischemia NIH | 0.30 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002561 | Cerebrovascular Disorders NIH | 0.27 |
| D019462 | Syncope, Vasovagal NIH | 0.27 |
| D014652 | Vascular Diseases NIH | 0.27 |
| D003324 | Coronary Artery Disease NIH | 0.27 |
| D013575 | Syncope NIH | 0.27 |
| D054144 | Heart Failure, Diastolic NIH | 0.27 |
| D013616 | Tachycardia, Sinus NIH | 0.27 |
| D023903 | Coronary Restenosis NIH | 0.27 |
| D013896 | Thoracic Diseases NIH | 0.19 |
| D002546 | Ischemic Attack, Transient NIH | 0.19 |
| D007511 | Ischemia NIH | 0.19 |
| D000073296 | Noncommunicable Diseases NIH | 0.19 |
| D054143 | Heart Failure, Systolic NIH | 0.19 |
| D013610 | Tachycardia NIH | 0.19 |
| D007022 | Hypotension NIH | 0.19 |
| D007238 | Infarction NIH | 0.16 |
| D015673 | Fatigue Syndrome, Chronic NIH | 0.15 |
| D000072657 | ST Elevation Myocardial Infarction NIH | 0.15 |
| D006333 | Heart Failure NIH | 0.15 |
| D001281 | Atrial Fibrillation NIH | 0.13 |
| D016584 | Panic Disorder NIH | 0.13 |
| D006470 | Hemorrhage NIH | 0.13 |
| D005356 | Fibromyalgia NIH | 0.12 |
| D003693 | Delirium NIH | 0.12 |
| D054058 | Acute Coronary Syndrome NIH | 0.11 |
| D002318 | Cardiovascular Diseases NIH | 0.09 |
| D050177 | Overweight NIH | 0.09 |
| D008173 | Lung Diseases, Obstructive NIH | 0.07 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.07 |
| D004617 | Embolism NIH | 0.06 |
| D012120 | Respiration Disorders NIH | 0.06 |
| D008171 | Lung Diseases, NIH | 0.05 |
| D012140 | Respiratory Tract Diseases NIH | 0.05 |
| D007249 | Inflammation NIH | 0.05 |
| D003141 | Communicable Diseases NIH | 0.04 |
| D007239 | Infection NIH | 0.04 |
| D016638 | Critical Illness NIH | 0.03 |
| D014777 | Virus Diseases NIH | 0.03 |
| D013577 | Syndrome NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.02 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001627 | Abnormal heart morphology HPO | 0.31 |
| HP:0001658 | Myocardial infarction HPO | 0.30 |
| HP:0011703 | Sinus tachycardia HPO | 0.27 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001677 | Coronary artery atherosclerosis HPO | 0.27 |
| HP:0012668 | Vasovagal syncope HPO | 0.27 |
| HP:0001279 | Syncope HPO | 0.27 |
| HP:0001649 | Tachycardia HPO | 0.19 |
| HP:0002615 | Hypotension HPO | 0.19 |
| HP:0002326 | Transient ischemic attack HPO | 0.19 |
| HP:0001635 | Congestive heart failure HPO | 0.15 |
| HP:0004757 | Paroxysmal atrial fibrillation HPO | 0.13 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.09 |
| HP:0006536 | Pulmonary obstruction HPO | 0.07 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.07 |
| HP:0002088 | Abnormal lung morphology HPO | 0.05 |
Navigate: Correlations HPO
There are 14 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 yearsAfter 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 12Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways. Scientists have also found that the bacteria in the human gut (the gut microbiome) affect their metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect the levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often for too long, there is a greater chance of developing diseases such as diabetes and cardiovascular disease. The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in the human gut are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome. The study investigators are recruiting volunteers aged 18-70 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals on up to 8 days while wearing glucose monitors (Abbott Freestyle Libre) to measure their blood sugar levels. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record their appetite, food, physical activity and sleep using apps and wearable devices. They will be asked to collect a fecal and saliva sample before consuming the standardised meals, and to provide a fasted blood sample at the end of the study period.
Description: Species count in fecal sample
Measure: Gut microbiome species richness Time: 1 DayDescription: Measurement of blood lipids
Measure: Lipids Time: 3 daysDescription: Measurement of blood glucose
Measure: Glucose Time: 11 daysDescription: Record of sleep pattern using a wearable device (i.e. fitness watch)
Measure: Sleep Time: 10 daysDescription: Record of physical activity using a wearable device (i.e. fitness watch)
Measure: Physical activity Time: 10 daysDescription: Record of hunger and appetite patterns using a digital app
Measure: Hunger and appetite assessment Time: 10 daysDescription: C-peptide
Measure: Glucose metabolism Time: 3 daysDescription: Weighed food log
Measure: Dietary assessment Time: 10 daysDescription: Weight (kg)
Measure: Anthropometry Time: 1 dayDescription: Height (cm)
Measure: Anthropometry Time: 1 dayDescription: Hip and waist circumference (cm)
Measure: Anthropometry Time: 1 dayDescription: Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)
Measure: Metabolomics by NMR analysis Time: 1 dayDescription: Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.
Measure: Dietary assessment Time: 1 monthDescription: Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.
Measure: Covid-19 symptom assessment Time: 6 monthsDescription: Self-reported in-app question on daily frequency of adherence (categorical)
Measure: Adherence (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on hunger levels (categorical)
Measure: Hunger (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on weight (lbs)
Measure: Weight (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app Bristol Stool chart questoin (categorical)
Measure: Bristol Stool Category (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on bowel frequency
Measure: Bowel Frequency (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on energy levels (categorical)
Measure: Energy (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on alertness (categorical)
Measure: Alertness (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on stress (categorical)
Measure: Stress (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on mood (categorical)
Measure: Mood (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on daily frequency of activity (categorical)
Measure: Activity (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)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.
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 minutesThe ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer. The population of congenital heart disease (CHD) might also be at risk, however, no data is available in this group of patients. CHD is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with CHD exceeds the number of children, with an increasing prevalence of complex CHD. Approximately 200,000 children and 250,000 adults are living with a CHD in France today. The French Society of Cardiology, coordinator of this study, issued recommendations on March 14, 2020 for the French CHD population on the basis of expert opinions based essentially on the data published in the general population. Nevertheless, there is a need to provide scientific data on the impact of Covid-19 in the pediatric and adult CHD population. This study aims to assess the morbidity, the mortality and the risk factors associated with Covid-19 in patients with CHD in France
Description: Prevalence of Covid-19 infection in the overall CHD population
Measure: Prevalence of Covid-19 infection in the overall CHD population Time: through study completion, an average of 2 weeksDescription: Prevalence of Covid-19 infection per CHD sub-group
Measure: Prevalence of Covid-19 infection per CHD sub-group Time: through study completion, an average of 2 weeksDescription: Cardiovascular complications
Measure: Cardiovascular complications Time: through study completion, an average of 2 weeksDescription: Other complications
Measure: Other complications Time: through study completion, an average of 2 weeksDescription: Number of deaths
Measure: Number of deaths Time: through study completion, an average of 2 weeksBased on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied
Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2
Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3. Time: Visit 3 (90 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4 Time: Visit 4 (135 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5 Time: Visit 5 (180 +/- 5 days)Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled
Measure: Prevalence of IgG/IgM against SARS-CoV-2 Time: Screening Visit and Visit 3 (90 +/- 5 days)Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit
Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19. Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.
Measure: The impact of new cardiovascular events between the two study groups Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.
Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed
Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.
Description: Identify organ dysfunction after SARS-CoV-2 infections
Measure: Sequelae after COVID-19 Time: 12 months, extension if requiredContactless and widely available health monitoring technologies are of growing interest in the context of the worldwide COVID-19 pandemic. Remote photoplethysmography (rPPG) is a well-studied technology that interprets variations in skin colour related to blood flow which, when analysed with complex mathematical algorithm, generates vital sign readings. This technology has been refined and embedded in a smartphone app designed to acquire heart rate, respiratory rate and oxygen saturation using a front-facing smartphone camera. Preliminary data comparing the accuracy of smartphone rPPG readings with conventional vital sign monitor readings are promising; however, less than 5% of the population studied in the app development phase had oxygen saturation levels below 95% making it impossible to ensure reliability in these populations. The goal of this study is to compare readings acquired using this rPPG app with the readings from hospital grade, Health Canada approved vital signs monitors used in healthcare settings with a focus on subject with low oxygen saturations. We will also study other sociodemographic and clinical features that may influence the accuracy of the readings. This will be achieved by recruiting consenting adults presenting to care in acute care settings and a designated COVID outpatient clinic. Vital signs will be acquired using the rPPG app and conventional hospital vital sign monitors simultaneously. Readings will be repeated within 2-5 minutes when time permits. Statistical analysis will be performed to analyze the findings and determine the accuracy and precision of the rPPG app readings. It is expected that the vital sign readings acquired with the rPPG app will be almost identical to those acquired using hospital-grade monitors for all subjects regardless of age, gender, skin colour, COVID status and relevant comorbidities.
Description: Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.
Measure: Accuracy of rPPG heart rate Time: immediate; paired readingDescription: Accuracy of rPPG oxygen saturation compared to conventional vital sign monitor oxygen saturation readings. Comparison of discrepancy within each paired reading set.
Measure: Accuracy of rPPG oxygen saturation Time: immediate; paired readingDescription: Accuracy of rPPG respiratory rate compared to manual counting of respiratory rate over 60 seconds. Comparison of discrepancy within each paired reading set.
Measure: Accuracy of rPPG respiratory rate Time: immediate; paired readingDescription: Comparison of rPPG heart rate results obtained on a given patient on serial readings within 2 minutes of each other.
Measure: Reproducibility of rPPG heart rate readings Time: 2-5 minutesDescription: Comparison of rPPG oxygen saturation results obtained on a given patient on serial readings within 2 minutes of each other.
Measure: Reproducibility of rPPG oxygen saturation readings Time: 2-5 minutesDescription: Comparison of rPPG respiratory rate results obtained on a given patient on serial readings within 2 minutes of each other.
Measure: Reproducibility of rPPG respiratory rate readings Time: 2-5 minutesDescription: Analysis of accuracy of rPPG vital sign readings when stratified by oxygen saturation per conventional monitors stratified as follows: 95-100%; 90-94%; 85-89%; Less than 85%
Measure: Accuracy of rPPG readings by oxygen saturation level Time: immediate; stratified analysisDescription: Analysis of accuracy of rPPG vital sign readings when stratified by skin colour per the Fitzpatrick scale
Measure: Accuracy of rPPG readings by skin colour Time: immediate; stratified analysisDescription: Analysis of accuracy of rPPG vital sign readings when stratified for gender
Measure: Accuracy of rPPG readings by gender Time: immediate; stratified analysisDescription: Analysis of accuracy of rPPG vital sign readings when stratified by age group
Measure: Accuracy of rPPG readings by age Time: immediate; stratified analysisDescription: Analysis of accuracy of rPPG vital sign readings when stratified for COVID, respiratory conditions, cardiac conditions and vascular conditions.
Measure: Accuracy of rPPG readings by comorbidity Time: immediate; stratified analysisNon-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in adults.
Description: percentage of patients with non-infectious diseases relating to overall number of patients registered in study
Measure: rate of non-infectious diseases Time: 12 month since a moment of request of medical helpDescription: correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups
Measure: severity of COVID-19 depending on pre-existing diseases Time: 12 month since a moment of request of medical helpDescription: Registration of disability or change of disability status
Measure: disability registration / change of disability status Time: 12 month since a moment of request of medical helpDescription: rate of deaths among registered participants
Measure: rate of letal outcomes Time: 12 month since a moment of request of medical helpDescription: correlation between number of deaths and pre-existing diseases
Measure: rate of letal outcomes depending on pre-existing disease Time: 12 month since a moment of request of medical helpThe study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).
Description: The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.
Measure: Net Adverse Clinical Endpoints (NACE) Time: 1 yearDescription: Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke
Measure: Major adverse cardiac and cerebral events (MACCE) Time: 1 yearDescription: Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
Measure: Major or clinically relevant non-major bleeding (MCB) Time: 1 yearDescription: Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization
Measure: Target Lesion Failure (TLF) Time: 1 yearDescription: Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization
Measure: Target vessel failure (TVF) Time: 1 yearDescription: The composite endpoint of cardiovascular death, myocardial infarction and stroke
Measure: The composite of cardiovascular death, myocardial infarction and stroke Time: 1 yearDescription: The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5
Measure: The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5 Time: 1 yearDescription: Stent thrombosis according to the ARC definitions
Measure: Stent thrombosis Time: 1 yearDescription: Myocardial infarction.
Measure: Myocardial infarction Time: 1 yearDescription: Urgent target vessel revascularization.
Measure: Urgent target vessel revascularization Time: 1 yearDescription: Non-target vessel revascularization.
Measure: Non-target vessel revascularization Time: 1 yearDescription: Clinically indicated target vessel revascularization.
Measure: Clinically indicated target vessel revascularization Time: 1 yearDescription: Bleeding events according to the BARC, TIMI and GUSTO classification
Measure: Bleeding events Time: 1 yearDescription: Transfusion rates both in patients with and/or without clinically detected over bleeding
Measure: Transfusion rates Time: 1 yearDescription: Event rates according to the PRECISE-DAPT score
Measure: Event rates according to the PRECISE-DAPT Time: 1 yearDescription: Procedural success is defined as angiographic success with no in-hospital MACE, defined as death, MI with new Q-waves on electrocardiogram (ECG) or urgent target vessel revascularization (TVR) (including both repeat PCI and coronary artery bypass graft surgery (CABG)
Measure: Procedural success Time: At completion of the baseline PCIDescription: Device success (applying a lesion-level analysis)
Measure: Device success Time: At discharge of baseline hospitalisation, on average 3 daysPatients are part of a family network. When any person in a family becomes critically unwell and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all members of that family. COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what effect these restrictions will have on patients' recovery, nor do we understand the impact it may have on their relatives or staff caring for them. This study will look at the implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact of these restrictions on them, their relatives and staff. This study will be carried out within a single specialised intensive care unit in Scotland using mixed methods. The first arm of this study will use retrospective data that is routinely collected in normal clinical practice. The investigators will compare patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions. The aim is to establish if the restrictions on visiting has an impact on the duration of delirium. Delirium is an acute mental confusion and is associated with longer hospital stays and worse outcomes in this patient group. The second arm of this study involves semi-structured interviews with patients, relatives and staff that will allow deeper exploration of the issues around current visiting policy. The interviews will last approximately 1 hour and will address these issues. They will then be transcribed word for word and analysed using grounded theory, meaning the theories will develop from the data as it is analysed.
Description: Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU)
Measure: Duration of delirium Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.Description: CAM-ICU
Measure: Incidence of delirium Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.Description: Days
Measure: Length of critical care stay Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.Description: Days
Measure: Length of hospital stay Time: From the date of admission to the hospital until discharge from the hospital or death, whichever came first, up to 12 months.Description: Days
Measure: Length of time ventilated Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.Description: Semi structured interviews
Measure: Exploring the experiences of patients, relatives and staff of the visitation restrictions during the COVID-19 pandemic Time: 18 monthsThe 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 monthsIn this three-party collaboration, which includes The Texas Center for Pediatric and Congenital Heart Disease, the Value Institute for Health and Care, and the Design Institute for Health, all from University of Texas (UT) Dell Medical School, the investigators will explore how patient insights, data, storytelling, ideation, and prototyping can be employed to design a care delivery solution that enables patient outcome improvement. The goal of this project is to understand the life journey of patients with single-ventricle congenital heart disease and understand areas of that journey that can be improved. As such, the project intentionally does not start with a hypothesis, but instead seeks to gain insight of single-ventricle patients' care journey and based on that understanding identify opportunities for improvement.
Description: This is a qualitative research study. The investigators are using a combination of Experience Group sessions, Contextual Interviews and workshops with patients and their family members to obtain information to identify areas of the lifelong journey of patient with single-ventricle congenital heart disease and their families that can be redesigned to improve the outcomes that matter most to the patients and their families
Measure: Identification of areas to be improved in patient and families' journey Time: 2 yearsAlphabetical 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