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Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02880605
Enrollment
11235
Registered
2016-08-26
Start date
2016-08-31
Completion date
2018-10-31
Last updated
2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appropriate Use Criteria, Coronary Revascularization

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.

Interventions

None listed

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiac and cerebrovascular events (MACCE)1 yeardeath, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization

Secondary

MeasureTime frameDescription
death1 year
recurrent hospitalizations for acute coronary syndrome (ACS)1 year
cerebrovascular event1 year
repeat revascularization1 year
cost for hospitalization1 yearTotal cost of hospitalization and rehospitalization for cardiac disease in follow-up time

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026