Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

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.

Study Overview

• Status: Completed
• Conditions: Coronary Revascularization; Appropriate Use Criteria

• Study Type: Observational
• Enrollment (Actual): 11235

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergo elective coronary angiography in department of cardiology in period of study.

Patients are written informed consent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
appropriate in appropriate indications
inappropriate in appropriate indications
appropriate in inappropriate indications
inappropriate in inappropriate indications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac and cerebrovascular events (MACCE)	death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Publications and helpful links

General Publications

• Lin S, Zhang H, Chen SP, Rao CF, Wu F, Zhou FJ, Wang Y, Yan HB, Dou KF, Wu YJ, Tang YD, Xie LH, Guan CD, Xu B, Zheng Z. Mis-estimation of coronary lesions and rectification by SYNTAX score feedback for coronary revascularization appropriateness. Chin Med J (Engl). 2020 Jun 5;133(11):1276-1284. doi: 10.1097/CM9.0000000000000827.
• Lin S, Zhang H, Rao CF, Chen SP, Qiao SB, Yan HB, Dou KF, Wu YJ, Tang YD, Yang XC, Shen ZJ, Liu J, Zheng Z; Beijing Coronary Angiography Registry Collaborative Group. Assessing the association of appropriateness of coronary revascularization and 1-year clinical outcomes for patients with stable coronary artery disease in China. Chin Med J (Engl). 2020 Jan 5;133(1):1-8. doi: 10.1097/CM9.0000000000000592.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2016-1-4031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No