Cardiometabolic Diseases
Conditions
Keywords
cardiometabolic diseases, atherosclerotic cardiovascular disease, diabetes
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Weill Cornell Medical College in Qatar
Hamad Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 1. 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: 1. Coronary Artery Disease (CAD) * Myocardial infarction (ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI)) * Stable or unstable angina with angiographic stenosis ≥50% * History of coronary revascularization (Percutaneous coronary intervention (PCI) or Coronary artery bypass graft surgery (CABG)) 2. Cerebrovascular Disease * Ischemic stroke or transient ischemic attack (TIA) * Symptomatic carotid artery stenosis ≥50% or prior carotid intervention 3. Peripheral Arterial Disease (PAD) * Intermittent claudication with objective evidence of arterial obstruction * Prior peripheral revascularization, limb amputation due to ischemia, or Ankle-brachial index ABI \<0.9 4. Aortic Atherosclerotic Disease •Aortic aneurysm (abdominal or thoracic) of atherosclerotic origin ii.Unequivocally Documented ASCVD on Imaging: <!-- --> 1. Coronary artery calcium (CAC) score \>100 Agatston units or \>75th percentile for age and sex 2. Coronary CT angiography or invasive angiography showing ≥50% stenosis in ≥1 major epicardial artery 3. Carotid ultrasound or angiography showing plaque or ≥50% stenosis 4. Lower-limb CT/MR/Doppler angiography showing atherosclerotic plaque or stenosis ≥50% 2. Very High Cardiovascular Risk i. In non-diabetic patients (ESC 2021 CVD Prevention Guidelines): * 10-year fatal/non-fatal ASCVD risk ≥10% using SCORE2 (ages 40-69), or ≥15% using SCORE2-OP (≥70 years) * Severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² ii.In diabetic patients (ESC 2023 Diabetes \& CVD Guidelines): * 10-year cardiovascular risk ≥20% using SCORE2-Diabetes * Severe target organ damage: <!-- --> 1. eGFR \<45 mL/min/1.73m² (regardless of albuminuria) 2. eGFR 45-59 mL/min/1.73m² with microalbuminuria (UACR 30-300 mg/g) or proteinuria (UACR \>300 mg/g) 3. Microvascular disease in at least three sites (e.g., microalbuminuria, retinopathy, neuropathy)
Exclusion criteria
* Type 1 diabetes or monogenic diabetes (e.g., MODY). * Pregnancy (self-reported). * Active cancer, under medical or radiation therapy or terminal, or cancer in remission \< 1 year. * Chronic immune or chronic infectious diseases. * End stage renal disease (ESRD) (estimated glomerular filtration rate \<15 mL/min/1.73m²). * Prisoners. * Inability or unwillingness to provide informed consent, including language barriers. * Mental incapacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes) | Baseline, Year 1, and Year 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index (BMI) | Baseline, Year 1, and Year 5 | Change in BMI (kg/m²) from baseline (Year 0) to Year 1 and Year 5. |
| Change in waist-to-hip ratio | Baseline, Year 1, and Year 5 | Change in waist-to-hip ratio from baseline (Year 0) at Year 1 and Year 5. |
| Change in fasting glucose | Baseline, Year 1, and Year 5. | Change in fasting glucose from baseline (Year 0) at Year 1 and Year 5. |
| Change in glycated hemoglobin (HbA1c) | Baseline, Year 1, and Year 5 | Change in HbA1c (%) from baseline (Year 0) at Year 1 and Year 5. |
| Change in lipid profile parameters | Baseline, Year 1, and Year 5. | 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. |
| Change in systolic and diastolic blood pressure | Baseline, Year 1, and Year 5 | Change in systolic and diastolic blood pressure (mmHg) from baseline (Year 0) at Year 1 and Year 5. |
| Electrocardiogram (ECG) - Heart Rate | Baseline, Year 1, and Year 5. | 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." |
| ECG - PR interval | Baseline, Year 1, and Year 5. | 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." |
| ECG - QTc interval | Baseline, Year 1, and Year 5 | 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." |
| ECG- QRS Duration | Baseline, Year 1, and Year 5. | 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. |
| Liver Stiffness Measurement | Baseline, Year 1, and Year 5 | Change in liver stiffness (kPa) assessed by Fibroscan from baseline (Year 0) at Year 1 and Year 5 |
| Controlled Attenuation Parameter | Baseline, Year 1, and Year 5] | 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. |
| Left Ventricular Ejection Fraction - LVEF | Baseline, Year 1, and Year 5. | Transthoracic echocardiography will be performed using standard imaging protocols. Parameters assessed will include left ventricular ejection fraction (LVEF, %). |
| Left Ventricular Mass Index | Baseline, Year 1, and Year 5. | Transthoracic echocardiography will be performed using standard imaging protocols. Parameters assessed will include left ventricular mass index unit- (g/m²). |
| E/e' Ratio | Baseline, Year 1, and Year 5. | Ratio of mitral inflow velocity to mitral annular tissue velocity; estimates left ventricular filling pressures and diastolic dysfunction severity assessed by Transthoracic echocardiography. |
| E/A Ratio | Baseline, Year 1, and Year 5. | Ratio of early (E) to late (A) mitral inflow velocities; used to assess left ventricular diastolic filling pattern to be assessed by Transthoracic echocardiography. |
| Pulmonary Artery Systolic Pressure - PASP | Baseline, Year 1, and Year 5. | 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. |
| Tricuspid Annular Plane Systolic Excursion - TAPSE | Baseline, Year 1, and Year 5. | Measure longitudinal movement of the tricuspid annulus, indicator of right ventricular systolic function in Transthoracic echocardiography unit mm. |
| Incidence of major adverse cardiovascular events (4-point MACE) | Baseline (Year 0), Year 1, and Year 5 | 4-point MACE will be defined as a composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular mortality, and hospitalization for unstable angina |
| Incidence of new-onset cardiac diseases and cardiovascular revascularization procedures | Baseline (Year 0), Year 1, Year 5 | 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. |
| Incidence of new non-cardiac diseases requiring hospitalization | Baseline (Year 0), Year 1, and Year 5 | 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). |
Countries
Qatar
Contacts
CONTACTCharbel Abi khalil, MD,PhD
PRINCIPAL_INVESTIGATORCharbel Abi Khalil, MD,PhD
Weill Cornell Medicine-Qatar
Outcome results
None listed