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临床试验/NCT03427489
NCT03427489已完成不适用

A Biorepository for Discovering Novel Biochemical and Genetic Markers of Coronary Heart Disease in Qatar (QCBio)

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 2,100 人开始时间: 2013年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,100
试验地点
1
主要终点
Identification of genetic variants associated with CHD in Qatari Individuals using whole genome sequencing on the 2000 samples stored at the genetic biorepository over 3 years.

研究概览

简要总结

Coronary heart disease (CHD) poses a major health burden in the Gulf countries. It is the leading cause of mortality and morbidity in the world and poses an enormous societal burden in the Gulf countries. Early detection of disease is imperative to reduce the health care burden and financial costs associated with CHD. Knowledge of novel genetic and proteomic markers of CHD will provide more precise estimates of risk while defining the pathways important in individual patients, revealing new targets for intervention, and ultimately enabling an individualized approach to care.

To translate recent advances in genomics and proteomics into clinical practice, these newly discovered biomarkers will need to be evaluated in patients of diverse ethnic groups with varying characteristics, environmental factors, and medication use. The investigators propose to establish a biorepository of plasma and Deoxyribonucleic acid (DNA) linked to demographic and clinical variables to facilitate biomarker studies of CHD risk, progression, and outcome. The overarching goal in developing the Qatar Cardiovascular Biorepository (QCBio) is to create a resource that fosters research aimed at identifying novel biochemical and genetic markers of CHD. A biorepository with linkage to clinical data will also provide an invaluable resource for cardiovascular research, including genomic and proteomic studies of CHD and development of biomarkers for early detection of disease and personalized drug therapy (pharmacogenetics and pharmacoproteomics).

详细描述

INTRODUCTION:

Prediction of Coronary heart disease (CHD) events is based on conventional risk factors for atherosclerosis such as age, sex, blood pressure, diabetes, lipid levels, and smoking status. Because these risk factors are prevalent in much of the population, available risk prediction algorithms lack desired sensitivity and specificity. For instance, Cooper et al showed that the algorithms correctly predicted just ~11% of the CHD events occurring within 10 years. Thus, there is an urgent need to develop and validate new biomarkers for early detection of disease and more accurate risk stratification. According to the World Health Organization (WHO) estimates, cardiovascular disease will be the leading cause of morbidity and mortality by the year 2020. Developing countries including the Gulf States will be the major contributors to this increased death and disability. A recent report by McKinsey & Company forecast that the Gulf region will face an unparalleled and unprecedented rise in demand for health care over the course of the next two decades, with an estimated total health care spending of US$ 60 billion in 2025, up from US$ 12 billion today.

Knowledge of novel genetic and proteomic markers will provide more precise estimates of risk while defining the pathways important in individual patients, revealing new targets for intervention, and ultimately enabling an individualized approach to care. A biorepository of Deoxyribonucleic acid (DNA), serum, and plasma samples will enable investigation of the pathogenesis of CHD in Qatari adults, and provide an invaluable resource for preventive cardiovascular research and development of biomarkers for early detection of CHD.

SIGNIFICANCE Significant recent progress has been made in identifying genetic susceptibility variants as well as circulating proteomic markers of atherosclerotic vascular disease. However, the generalizability of these results to patients belonging to diverse ethnic groups is unclear. To translate recent advances in genomics and proteomics into clinical practice, these newly discovered biomarkers will need to be evaluated in patients of diverse ethnic groups with varying characteristics, environmental factors, and medication use. The investigators propose to establish a biorepository of plasma and DNA linked to demographic and clinical variables to facilitate biomarker studies of CHD risk, progression, and outcome. The overarching goal in developing the Qatar Cardiovascular Biorepository (QCBio) is to create a resource that fosters research aimed at identifying novel biochemical and genetic markers of CHD.

RESEARCH DESIGN AND METHODS:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects: History or clinical diagnosis of Acute Coronary Syndrome
  • Controls: No history of Coronary Heart disease.

排除标准

  • Chronic or infectious disease
  • Vulnerable populations (Children, prisoners, cognitive impairment)

结局指标

主要结局

Identification of genetic variants associated with CHD in Qatari Individuals using whole genome sequencing on the 2000 samples stored at the genetic biorepository over 3 years.

时间窗: Three years

QCBio will create an unparalleled and unique resource for conducting genomic and studies to identify and validate biomarkers for diagnosis, prognostication, and response to therapy, in Qataris patients who have CHD or at risk

次要结局

  • Identification of circulating markers using plasma proteomic and metabolomic analysis in 2000 Qatari individuals with and without CHD.(Three years)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dr. Ayman El-Menyar

Associate Professor

Hamad Medical Corporation

研究点 (1)

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