Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

Coronary Revascularization Clinical Trial

Official title:

Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880605
• Other study ID #: 2016-1-4031
• Status: Completed
• Start date: August 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11235
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appropriate Use Criteria
• Coronary Revascularization

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebrovascular events (MACCE)	death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization	1 year
Secondary	death		1 year
Secondary	recurrent hospitalizations for acute coronary syndrome (ACS)		1 year
Secondary	cerebrovascular event		1 year
Secondary	repeat revascularization		1 year
Secondary	cost for hospitalization	Total cost of hospitalization and rehospitalization for cardiac disease in follow-up time	1 year