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临床试验/NCT03072797
NCT03072797Unknown不适用

Beijing Hospital Atherosclerosis Study

Beijing Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年3月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
Number of participants with major adverse cardiovascular events (MACE)

研究概览

简要总结

The Beijing Hospital Atherosclerosis Study (BHAS) is a prospective, single-center, observational cohort study performed at the Beijing Hospital in Beijing, China. Subjects enrolled in this study will be the consecutive patients undergoing coronary angiography in the hospital. Blood samples are taken immediately before the angiographic procedure. Clinical and angiographic characteristics are recorded. All patients will have routine follow-up at 6 months and 1 year postprocedure, then yearly thereafter. Follow-up includes mortality, myocardial infarction (MI), stroke, rehospitalization, coronary revascularization procedures, life styles, and medication use. The primary end point for the study will be the major adverse cardiovascular events (MACE), defined as death from any cause, nonfatal myocardial infarction, nonfatal stroke and revascularization. This study has been reviewed and approved by the Ethics Committee of Beijing Hospital. All enrolled individuals will be received written notice of the intended use of their blood samples and provided written consent.

The major objectives of the BHAS Study are to (1) establish a prospective cohort and a biological sample bank in ethnic Chinese with coronary angiography, (2) identify baseline new biosignature profiles such as novel biomarkers via metabolomics approach associated with the subsequent clinical events, (3) assess the use of molecular profiles from multiple platforms (eg, genomics, proteomics, and metabolomics) integrated with readily available clinical information for improved risk classification for cardiovascular events, and (4) provide clearer understanding of underlying disease processes.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Age >18y
  • Consent for the study
  • Primary reason for catheterization is concern for ischemic heart disease
  • Complete clinical and coronary angiogram data available

排除标准

  • Primary pulmonary hypertension or severe lung disease
  • Cardiac transplantation
  • Other solid organ transplant
  • Peripheral vascular intervention only
  • Right heart catheterization only
  • Advanced heart failure
  • Congenital heart disease
  • Women who are pregnant or nursing, or preparing for pregnant during the study period
  • Progressive fatal disease
  • History of alcoholism or drug abuse
  • Patients with mental illness and are being treated
  • Patients are undergoing radiotherapy or chemotherapy
  • Acute and chronic infectious diseases

结局指标

主要结局

Number of participants with major adverse cardiovascular events (MACE)

时间窗: 3 years

MACE include death from any cause, nonfatal myocardial infarction, nonfatal stroke and revascularization.

次要结局

  • Number of participants with other atherosclerosis events(3 years)

研究者

发起方
Beijing Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fusui Ji, MD

Director, Department of Gerontological Cardiology

Beijing Hospital

研究点 (1)

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