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Qatar Cardiometabolic Cohort

23. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

3000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Katar
      • Doha, Katar
        • Hamad Medical Corporation
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Participants will be recruited at Hamad Medical Corporation

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in body mass index (BMI)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Weill Cornell Medical College in Qatar

Mitarbeiter

Hamad Medical Corporation

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juni 2036

Studienabschluss (Geschätzt)

30. Juni 2036

Studienanmeldedaten

Zuerst eingereicht

6. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juni 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 26-00001

Plan für individuelle Teilnehmerdaten (IPD)

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Beschreibung des IPD-Plans

ongoing discussion with the sponsor

Arzneimittel- und Geräteinformationen, Studienunterlagen

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Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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