心血管代謝疾患の臨床試験-臨床試験登録-ICH GCP

調査の概要

状態

まだ募集していません

条件

心血管代謝疾患

詳細な説明

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.

研究の種類

観察的

入学 (推定)

3000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Charbel Abi khalil, MD,PhD
電話番号：+974 4492 8484
メール：cha2022@qatar-med.cornell.edu

研究場所

カタール
- - Doha、カタール
    - Hamad Medical Corporation
    - コンタクト：
      
      Jassim Al Suwaidi, MD
      
      電話番号：+974 4439 5354
      
      メール：jalsuwaidi@hamad.qa

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Participants will be recruited at Hamad Medical Corporation

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

3

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Comparison of the incidence of the of major adverse cardiovascular events between the three groups (control, pre-diabetes, and diabetes) 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Change in body mass index (BMI) 時間枠：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 時間枠：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 時間枠：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) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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) 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Weill Cornell Medical College in Qatar

協力者

Hamad Medical Corporation

捜査官

主任研究者：Charbel Abi Khalil, MD,PhD、Weill Cornell Medicine-Qatar

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2036年6月30日

研究の完了 (推定)

2036年6月30日

試験登録日

最初に提出

2026年4月6日

QC基準を満たした最初の提出物

2026年6月23日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)