Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

Completed

• Conditions: Coronary Revascularization; Appropriate Use Criteria

• Registration Number: NCT02880605
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-18
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11235

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	1 year	death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization

Secondary Outcome Measures

Name	Time	Method
repeat revascularization	1 year
death	1 year
recurrent hospitalizations for acute coronary syndrome (ACS)	1 year
cerebrovascular event	1 year
cost for hospitalization	1 year	Total cost of hospitalization and rehospitalization for cardiac disease in follow-up time

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China