Qatar Cardiometabolic Cohort

Official title

Qatar Cardiometabolic Cohort (QCMC)

Overview

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.

Primary outcome measures

• Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes) [Time frame: Baseline, Year 1, and Year 5]

Secondary outcome measures (12)

• Change in body mass index (BMI) [Time frame: Baseline, Year 1, and Year 5]
• Change in waist-to-hip ratio [Time frame: Baseline, Year 1, and Year 5]
• Change in fasting glucose [Time frame: Baseline, Year 1, and Year 5.]
• Change in glycated hemoglobin (HbA1c) [Time frame: Baseline, Year 1, and Year 5]
• Change in lipid profile parameters [Time frame: Baseline, Year 1, and Year 5.]
• Change in systolic and diastolic blood pressure [Time frame: Baseline, Year 1, and Year 5]
• Electrocardiogram (ECG) - Heart Rate [Time frame: Baseline, Year 1, and Year 5.]
• ECG - PR interval [Time frame: Baseline, Year 1, and Year 5.]
• ECG - QTc interval [Time frame: Baseline, Year 1, and Year 5]
• ECG- QRS Duration [Time frame: Baseline, Year 1, and Year 5.]
• Liver Stiffness Measurement [Time frame: Baseline, Year 1, and Year 5]
• Controlled Attenuation Parameter [Time frame: Baseline, Year 1, and Year 5]]

Eligibility criteria

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)

• 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))
• Cerebrovascular Disease

• Ischemic stroke or transient ischemic attack (TIA)
• Symptomatic carotid artery stenosis ≥50% or prior carotid intervention
• 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
• Aortic Atherosclerotic Disease •Aortic aneurysm (abdominal or thoracic) of atherosclerotic origin ii.Unequivocally Documented ASCVD on Imaging:

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• Coronary artery calcium (CAC) score >100 Agatston units or >75th percentile for age and sex
• Coronary CT angiography or invasive angiography showing ≥50% stenosis in ≥1 major epicardial artery
• Carotid ultrasound or angiography showing plaque or ≥50% stenosis
• Lower-limb CT/MR/Doppler angiography showing atherosclerotic plaque or stenosis ≥50%
• 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:

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• eGFR <45 mL/min/1.73m² (regardless of albuminuria)
• eGFR 45-59 mL/min/1.73m² with microalbuminuria (UACR 30-300 mg/g) or proteinuria (UACR >300 mg/g)
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Qatar · 1 center

• Hamad Medical Corporation — Doha

Identifiers

NCT: NCT07675928 · 26-00001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗