Clinical trial NCT02880605: Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization
Official title: Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appropriate Use Criteria
Coronary Revascularization
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2016-08-26
Enrollment: 11235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 1 year
Secondary outcomes:
measure: death
timeFrame: 1 year
measure: recurrent hospitalizations for acute coronary syndrome (ACS)
timeFrame: 1 year
measure: cerebrovascular event
timeFrame: 1 year
measure: repeat revascularization
timeFrame: 1 year
measure: cost for hospitalization
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.