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OpenTrials
Completed

NCT Number: NCT02880605

Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: 1 year

    death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization

Secondary outcomes

  1. death

    Time frame: 1 year

  2. recurrent hospitalizations for acute coronary syndrome (ACS)

    Time frame: 1 year

  3. cerebrovascular event

    Time frame: 1 year

  4. repeat revascularization

    Time frame: 1 year

  5. cost for hospitalization

    Time frame: 1 year

    Total cost of hospitalization and rehospitalization for cardiac disease in follow-up time

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 26, 2016
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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