Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging :A Cohort Study of China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography angiography (CTA). The endpoint was major adverse cardiac events (MACE).The investigator aim to evaluate the prognostic value of CTA, risk factors and bio-markers for MACE.
详细描述
The investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography (CT). Cardiac CT was assessed for coronary artery calcification score (CACS) and the extent, the location, the stenosis severity, and the composition of the plaque in CTA. The base line information was recorded, including risk factors, drugs, bio-markers, and psychological. The endpoint was MACE, defined as composite cardiac death, nonfatal myocardial infarction (MI).we aim to evaluate the prognostic value of CTA, risk factors and bio-markers for major adverse cardiac events (MACE).
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
- 否
入选标准
- •suspected of coronary heart disease, coronary CTA has been completed.
- •age > 18 years old.
- •have biochemical test results.
- •signed informed consent.
排除标准
- •malignant tumor, severe liver and kidney diseases.
- •combination of cardiomyopathy, valvular disease, congenital heart disease, a variety of reasons the left cardiac insufficiency.
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 3 years
cardiac death, myocardial infarction (Cardiac death was defined as death due to acute myocardial infarction, ventricular arrhythmias, refractory heart failure or cardiogenic shock. The investigator reviewed all available data to determine whether a cardiac etiology was the immediate cause of death and categorized cardiac deaths into sudden cardiac death and nonsudden cardiac death. Sudden cardiac death was defined by published criteria . myocardial infarction was defined based on the criteria of typical chest pain, elevated cardiac enzyme levels and typical alterations of the electrocardiogram. )
次要结局
未报告次要终点
研究者
Bin Lu
Director of radiology department
Chinese Academy of Medical Sciences, Fuwai Hospital