Ensaio clínico em Doenças Cardiometabólicas - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Doenças Cardiometabólicas

Descrição detalhada

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 de estudo

Observacional

Inscrição (Estimado)

3000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Charbel Abi khalil, MD,PhD
Número de telefone: +974 4492 8484
E-mail: cha2022@qatar-med.cornell.edu

Locais de estudo

Catar
- - Doha, Catar
    - Hamad Medical Corporation
    - Contato:
      
      Jassim Al Suwaidi, MD
      
      Número de telefone: +974 4439 5354
      
      E-mail: jalsuwaidi@hamad.qa

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Participants will be recruited at Hamad Medical Corporation

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

3

Coortes e Intervenções

Grupo / 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes) Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change in body mass index (BMI) Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Weill Cornell Medical College in Qatar

Colaboradores

Hamad Medical Corporation

Investigadores

Investigador principal: Charbel Abi Khalil, MD,PhD, Weill Cornell Medicine-Qatar

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

30 de junho de 2036

Conclusão do estudo (Estimado)

30 de junho de 2036

Datas de inscrição no estudo

Enviado pela primeira vez

6 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de junho de 2026

Primeira postagem (Real)

30 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)