Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

NCT ID: NCT02880605

Last Updated: 2018-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Appropriate Use Criteria Coronary Revascularization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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appropriate in appropriate indications

No interventions assigned to this group

inappropriate in appropriate indications

No interventions assigned to this group

appropriate in inappropriate indications

No interventions assigned to this group

inappropriate in inappropriate indications

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32452896 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31923098 (View on PubMed)

Other Identifiers

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2016-1-4031

Identifier Type: -

Identifier Source: org_study_id

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