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Qatar Cardiometabolic Cohort

23 juni 2026 uppdaterad av: Weill Cornell Medical College in Qatar

Qatar Cardiometabolic Cohort (QCMC)

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.

Studieöversikt

Status

Har inte rekryterat ännu

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

3000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

      • Doha, Qatar
        • Hamad Medical Corporation
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Participants will be recruited at Hamad Medical Corporation

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes)
Tidsram: 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.

Baseline, Year 1, and Year 5

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in body mass index (BMI)
Tidsram: Baseline, Year 1, and Year 5
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
Tidsram: Baseline, Year 1, and Year 5
Change in waist-to-hip ratio from baseline (Year 0) at Year 1 and Year 5.
Baseline, Year 1, and Year 5
Change in fasting glucose
Tidsram: Baseline, Year 1, and Year 5.
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)
Tidsram: Baseline, Year 1, and Year 5
Change in HbA1c (%) from baseline (Year 0) at Year 1 and Year 5.
Baseline, Year 1, and Year 5
Change in lipid profile parameters
Tidsram: 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.
Baseline, Year 1, and Year 5.
Change in systolic and diastolic blood pressure
Tidsram: Baseline, Year 1, and Year 5
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
Tidsram: 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."
Baseline, Year 1, and Year 5.
ECG - PR interval
Tidsram: 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."
Baseline, Year 1, and Year 5.
ECG - QTc interval
Tidsram: 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."
Baseline, Year 1, and Year 5
ECG- QRS Duration
Tidsram: 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.
Baseline, Year 1, and Year 5.
Liver Stiffness Measurement
Tidsram: Baseline, Year 1, and Year 5
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
Tidsram: 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.
Baseline, Year 1, and Year 5]
Left Ventricular Ejection Fraction - LVEF
Tidsram: Baseline, Year 1, and Year 5.
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
Tidsram: 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).
Baseline, Year 1, and Year 5.
E/e' Ratio
Tidsram: 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.
Baseline, Year 1, and Year 5.
E/A Ratio
Tidsram: 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.
Baseline, Year 1, and Year 5.
Pulmonary Artery Systolic Pressure - PASP
Tidsram: 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.
Baseline, Year 1, and Year 5.
Tricuspid Annular Plane Systolic Excursion - TAPSE
Tidsram: Baseline, Year 1, and Year 5.
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)
Tidsram: 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
Baseline (Year 0), Year 1, and Year 5
Incidence of new-onset cardiac diseases and cardiovascular revascularization procedures
Tidsram: 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.
Baseline (Year 0), Year 1, Year 5
Incidence of new non-cardiac diseases requiring hospitalization
Tidsram: 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).
Baseline (Year 0), Year 1, and Year 5

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Charbel Abi Khalil, MD,PhD, Weill Cornell Medicine-Qatar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

30 juni 2036

Avslutad studie (Beräknad)

30 juni 2036

Studieregistreringsdatum

Först inskickad

6 april 2026

Först inskickad som uppfyllde QC-kriterierna

23 juni 2026

Första postat (Faktisk)

30 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juni 2026

Senast verifierad

1 april 2026

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