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Qatar Cardiometabolic Cohort

23 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

3000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Qatar
      • Doha, Qatar
        • Hamad Medical Corporation
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Participants will be recruited at Hamad Medical Corporation

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in body mass index (BMI)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Weill Cornell Medical College in Qatar

Collaboratori

Hamad Medical Corporation

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

30 giugno 2036

Completamento dello studio (Stimato)

30 giugno 2036

Date di iscrizione allo studio

Primo inviato

6 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 giugno 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26-00001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

ongoing discussion with the sponsor

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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