Qatar Cardiometabolic Cohort

Официальное название

Qatar Cardiometabolic Cohort (QCMC)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Катар · 1 центр

• Hamad Medical Corporation — Doha

Идентификаторы

NCT: NCT07675928 · 26-00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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