Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-09 @ 9:47 AM
Study NCT ID:
NCT02880605
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11235}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-18', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac and cerebrovascular events (MACCE)', 'timeFrame': '1 year', 'description': 'death, nonfatal myocardial infarction, cerebrovascular event, repeat revascularization'}], 'secondaryOutcomes': [{'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', 'description': 'Total cost of hospitalization and rehospitalization for cardiac disease in follow-up time'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Appropriate Use Criteria', 'Coronary Revascularization']}, 'referencesModule': {'references': [{'pmid': '32452896', 'type': 'DERIVED', '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.'}, {'pmid': '31923098', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThus 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergo elective coronary angiography in department of cardiology in period of study.\n\nPatients are written informed consent.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergo elective coronary angiography in department of cardiology in period of study\n* Written informed consent\n\nExclusion Criteria:\n\n* Age ≤18 years of age\n* Illiteracy, vision/audition disorder, cognitive disorder etc'}, 'identificationModule': {'nctId': 'NCT02880605', 'briefTitle': 'Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization', 'orgStudyIdInfo': {'id': '2016-1-4031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'appropriate in appropriate indications'}, {'label': 'inappropriate in appropriate indications'}, {'label': 'appropriate in inappropriate indications'}, {'label': 'inappropriate in inappropriate indications'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}