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| Name | Class |
|---|---|
| Hamad Medical Corporation | INDUSTRY |
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Our objective is to create a cardiometabolic cohort that could be representative of the local population, consisting of Qataris and long-term residents, in order to identify the prevalence, risk factors, and clinical characteristics of cardiometabolic disorders, as well as the incidence of atherosclerotic cardiovascular disease events.
Qatar, along with other Gulf Cooperation Council (GCC) countries, experiences one of the highest rates of diabetes, obesity, and cardiovascular risk factors. However, the impact of those risk factors on cardiac diseases, in particular atherosclerotic cardiovascular disease (ASCVD), is not well studied. Further, the incidence of mortality in participants with diabetes and high cardiovascular risk is not known.
We will conduct a prospective, longitudinal, observational cohort that investigates the natural history of cardiometabolic diseases in citizens and long-term residents in Qatar: the Qatar Cardiometabolic Cohort (QCMC). The cohort will examine the prevalence, risk factors, and characterization of cardiometabolic patients, as well as the incidence of mortality and ASCVD events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groupe 1: Controls (C) | Non-diabetic patients, defined as having an HbA1c < 5.7%, with established atherosclerotic cardiovascular disease (ASCVD) or very high cardiovascular risk | ||
| Groupe 2: Cases-1 (pre-D) | Patients with pre-diabetes, defined as having an HbA1c between 5.7≤HbA1C ≤6.4, with established atherosclerotic cardiovascular disease (ASCVD) or very high cardiovascular risk | ||
| Groupe 3: Cases-2 (T2D) | Patients with type 2 diabetes, defined as having an HbA1c ≥ 6.5%, with established atherosclerotic cardiovascular disease (ASCVD) or very high cardiovascular risk. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes) | To compare the incidence of major adverse cardiovascular events (3-point MACE: cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) across three groups of adults with established ASCVD or very high cardiovascular risk: non-diabetes, pre-diabetes, and type 2 diabetes. | Baseline, Year 1, and Year 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index (BMI) | Change in BMI (kg/m²) from baseline (Year 0) to Year 1 and Year 5. | Baseline, Year 1, and Year 5 |
| Change in waist-to-hip ratio | Change in waist-to-hip ratio from baseline (Year 0) at Year 1 and Year 5. |
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Inclusion Criteria:
Qataris
Long-term residents (≥15 years of residence in Doha) who are not planning to leave Qatar voluntarily within the next 5 years.
Age ≥18 years.
English or Arabic speaker.
Presence of either atherosclerotic cardiovascular disease (ASCVD) or very high cardiovascular risk.
ASCVD:
ASCVD is defined as either clinical ASCVD or unequivocally documented ASCVD on imaging, based on the European Society of Cardiology (ESC) guidelines for the management of cardiovascular disease in patients with diabetes.
i.Clinical ASCVD: History or presence of any of the following atherosclerotic events or revascularization in major arterial territories:
Coronary Artery Disease (CAD)
Cerebrovascular Disease
Peripheral Arterial Disease (PAD)
Aortic Atherosclerotic Disease •Aortic aneurysm (abdominal or thoracic) of atherosclerotic origin ii.Unequivocally Documented ASCVD on Imaging:
Very High Cardiovascular Risk i. In non-diabetic patients (ESC 2021 CVD Prevention Guidelines):
Exclusion Criteria:
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Participants will be recruited at Hamad Medical Corporation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charbel Abi khalil, MD,PhD | Contact | +974 4492 8484 | cha2022@qatar-med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Charbel Abi Khalil, MD,PhD | Weill Cornell Medicine-Qatar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Doha | Qatar |
ongoing discussion with the sponsor
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Blood and Urine
| Baseline, Year 1, and Year 5 |
| Change in fasting glucose | Change in fasting glucose from baseline (Year 0) at Year 1 and Year 5. | Baseline, Year 1, and Year 5. |
| Change in glycated hemoglobin (HbA1c) | Change in HbA1c (%) from baseline (Year 0) at Year 1 and Year 5. | Baseline, Year 1, and Year 5 |
| Change in lipid profile parameters | Parameters include total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides. Changes from baseline will be assessed at Year 1 and Year 5. | Baseline, Year 1, and Year 5. |
| Change in systolic and diastolic blood pressure | Change in systolic and diastolic blood pressure (mmHg) from baseline (Year 0) at Year 1 and Year 5. | Baseline, Year 1, and Year 5 |
| Electrocardiogram (ECG) - Heart Rate | ECGs will be evaluated for clinically significant abnormalities. Changes from baseline in heart rate -beats per minute will be assessed at Year 1 and Year 5." | Baseline, Year 1, and Year 5. |
| ECG - PR interval | ECGs will be evaluated for clinically significant abnormalities. Changes from baseline will be assessed in the PR interval (ms-milli second) at Year 1 and Year 5." | Baseline, Year 1, and Year 5. |
| ECG - QTc interval | ECGs will be evaluated for clinically significant abnormalities in the QTc interval in ms-milliseconds. Changes from baseline will be assessed at Year 1 and Year 5." | Baseline, Year 1, and Year 5 |
| ECG- QRS Duration | ECGs will be evaluated for clinically significant abnormalities in the QRS duration (ms-milli second). Changes from baseline will be assessed at Year 1 and Year 5. | Baseline, Year 1, and Year 5. |
| Liver Stiffness Measurement | Change in liver stiffness (kPa) assessed by Fibroscan from baseline (Year 0) at Year 1 and Year 5 | Baseline, Year 1, and Year 5 |
| Controlled Attenuation Parameter | Quantitative measure obtained by FibroScan (transient elastography) that assesses hepatic steatosis (liver fat content)- Unit: decibels per meter (dB/m) by measuring ultrasound attenuation in the liver. | Baseline, Year 1, and Year 5] |
| Left Ventricular Ejection Fraction - LVEF | Transthoracic echocardiography will be performed using standard imaging protocols. Parameters assessed will include left ventricular ejection fraction (LVEF, %). | Baseline, Year 1, and Year 5. |
| Left Ventricular Mass Index | Transthoracic echocardiography will be performed using standard imaging protocols. Parameters assessed will include left ventricular mass index unit- (g/m²). | Baseline, Year 1, and Year 5. |
| E/e' Ratio | Ratio of mitral inflow velocity to mitral annular tissue velocity; estimates left ventricular filling pressures and diastolic dysfunction severity assessed by Transthoracic echocardiography. | Baseline, Year 1, and Year 5. |
| E/A Ratio | Ratio of early (E) to late (A) mitral inflow velocities; used to assess left ventricular diastolic filling pattern to be assessed by Transthoracic echocardiography. | Baseline, Year 1, and Year 5. |
| Pulmonary Artery Systolic Pressure - PASP | Estimated pressure in the pulmonary artery derived from tricuspid regurgitation velocity; reflects pulmonary hypertension and right heart load will be measured using Transthoracic echocardiography in mmHg. | Baseline, Year 1, and Year 5. |
| Tricuspid Annular Plane Systolic Excursion - TAPSE | Measure longitudinal movement of the tricuspid annulus, indicator of right ventricular systolic function in Transthoracic echocardiography unit mm. | Baseline, Year 1, and Year 5. |
| Incidence of major adverse cardiovascular events (4-point MACE) | 4-point MACE will be defined as a composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular mortality, and hospitalization for unstable angina | Baseline (Year 0), Year 1, and Year 5 |
| Incidence of new-onset cardiac diseases and cardiovascular revascularization procedures | New-onset cardiac diseases will include heart failure, atrial fibrillation or other arrhythmias, and valvular heart disease. Cardiovascular revascularization procedures will include coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI/PTCA), carotid angioplasty, carotid endarterectomy, and lower limb revascularization. | Baseline (Year 0), Year 1, Year 5 |
| Incidence of new non-cardiac diseases requiring hospitalization | This outcome includes the development of any new non-cardiac medical condition requiring hospital admission, excluding cardiovascular causes. Hospitalizations will be categorized by system (e.g., infectious, respiratory, renal, gastrointestinal, or other medical causes). | Baseline (Year 0), Year 1, and Year 5 |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |