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临床试验/NCT02880605
NCT02880605已完成不适用

Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 11,235 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11,235
试验地点
1
主要终点
Major adverse cardiac and cerebrovascular events (MACCE)

研究概览

简要总结

Coronary revascularization (CR) is increasing rapidly in China and varies significantly in proportion ( PCI:CABG=15:1). Few studies assess the appropriateness of CR in China. Recently, National Center for Cardiovascular Disease organized experts to release Chinese version appropriate use criteria(C-AUC) for coronary revascularization by RAND method aimed at regulating indications of CR. The criteria is considered to contribute to clinical practices, quality assessment and health insurance policy, however, the validation of C-AUC is unknown.

Thus the investigators study aims at assessing the validation of Chinese AUC by multi-center prospective registry. The investigators will recruit 4000 patients undergoing elective coronary angiography with positive outcome consecutively and collect baseline information. Sequently, one-year follow up will be done to collect the prognose, including death, rehospitalization, medicine, medical compliance and life quality etc. One hand, the investigators will compare the outcomes between different therapies in the same indications according to C-AUC to evaluate the validation of C-AUC. On the other hand, the investigators will evaluate the rationality of CAD therapy in Beijing by C-AUC.

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

  • Undergo elective coronary angiography in department of cardiology in period of study
  • Written informed consent

排除标准

  • Age ≤18 years of age
  • Illiteracy, vision/audition disorder, cognitive disorder etc

结局指标

主要结局

Major adverse cardiac and cerebrovascular events (MACCE)

时间窗: 1 year

death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization

次要结局

  • death(1 year)
  • recurrent hospitalizations for acute coronary syndrome (ACS)(1 year)
  • cerebrovascular event(1 year)
  • cost for hospitalization(1 year)
  • repeat revascularization(1 year)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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