Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

NCT02880605 | Completed DMC

• 1 other identifier: 2016-1-4031
• Study Type: observational
• Target: 11,235
• Locations: 1 country
• Sites: 1

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.

Conditions

Appropriate Use Criteria; Coronary Revascularization

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebrovascular events (MACCE)

  death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization

  1 year

Secondary Outcomes (5)

• death

  1 year

• recurrent hospitalizations for acute coronary syndrome (ACS)

  1 year

• cerebrovascular event

  1 year

• repeat revascularization

  1 year

• cost for hospitalization

  1 year

Study Arms (4)

appropriate in appropriate indications

inappropriate in appropriate indications

appropriate in inappropriate indications

inappropriate in inappropriate indications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (2)

• 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.

  PMID: 32452896 DERIVED

• 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.

  PMID: 31923098 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)