Qatar Cardiometabolic Cohort (QCMC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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:
- •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:
- •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)
排除标准
- •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.
结局指标
主要结局
Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes)
时间窗: 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.
次要结局
- Change in body mass index (BMI)(Baseline, Year 1, and Year 5)
- Change in waist-to-hip ratio(Baseline, Year 1, and Year 5)
- Change in fasting glucose(Baseline, Year 1, and Year 5.)
- Change in glycated hemoglobin (HbA1c)(Baseline, Year 1, and Year 5)
- Change in lipid profile parameters(Baseline, Year 1, and Year 5.)
- Change in systolic and diastolic blood pressure(Baseline, Year 1, and Year 5)
- Electrocardiogram (ECG) - Heart Rate(Baseline, Year 1, and Year 5.)
- ECG - PR interval(Baseline, Year 1, and Year 5.)
- ECG - QTc interval(Baseline, Year 1, and Year 5)
- ECG- QRS Duration(Baseline, Year 1, and Year 5.)
- Liver Stiffness Measurement(Baseline, Year 1, and Year 5)
- Controlled Attenuation Parameter(Baseline, Year 1, and Year 5])
- Left Ventricular Ejection Fraction - LVEF(Baseline, Year 1, and Year 5.)
- Left Ventricular Mass Index(Baseline, Year 1, and Year 5.)
- E/e' Ratio(Baseline, Year 1, and Year 5.)
- E/A Ratio(Baseline, Year 1, and Year 5.)
- Pulmonary Artery Systolic Pressure - PASP(Baseline, Year 1, and Year 5.)
- Tricuspid Annular Plane Systolic Excursion - TAPSE(Baseline, Year 1, and Year 5.)
- Incidence of major adverse cardiovascular events (4-point MACE)(Baseline (Year 0), Year 1, and Year 5)
- Incidence of new-onset cardiac diseases and cardiovascular revascularization procedures(Baseline (Year 0), Year 1, Year 5)
- Incidence of new non-cardiac diseases requiring hospitalization(Baseline (Year 0), Year 1, and Year 5)