Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-01 @ 11:07 AM
Study NCT ID:
NCT02410993
Status:
UNKNOWN
Last Update Posted:
2018-07-17
First Post:
2015-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Current Treatment Strategy of Patients With Multivessel Disease or Left Main Coronary Artery Disease Indicated for Coronary Artery Bypass Graft Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-15', 'studyFirstSubmitDate': '2015-04-03', 'studyFirstSubmitQcDate': '2015-04-03', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients treated with PCI or medical treatment despite of recommendation for CABG surgery', 'timeFrame': '1 month (After the revascularization strategy was finally decided)'}], 'secondaryOutcomes': [{'measure': 'Reason of ineligibility for CABG surgery', 'timeFrame': '1 month (After the revascularization strategy was finally decided)'}, {'measure': 'the composite of major cardiac and cerebrovascular event (MACCE)', 'timeFrame': '1 year follow up after revascularization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'According to 2011 ACCF/AHA guideline and 2014 ESC/EACTS guideline, CABG surgery was recommended for three-vessel coronary artery disease and left main coronary artery disease in the patients with stable ischemic heart disease as class I. 2-VD with proximal left anterior descending artery stenosis was also indicated for CABG surgery as class I recommendation. However, many patients have been recommended for PCI by catheterization laboratory cardiologist; 46% and 93% in the only-CABG candidates and both CABG and PCI candidates, retrospectively, defined by previous ACC/AHA guideline. Although the discordance between real practice in catheterization laboratory and guideline would be adjusted by recently updated guideline. The revascularization strategy for patients with 3-VD/LMD in real practice have been getting toward more PCI and less CABG surgery. In this study, we will identify the rate of CABG candidates who were treated with PCI or medical treatment instead of CABG surgery in different from current guideline. We are also going to compare two treatment strategies CABG surgery vs. PCI with 2nd generation DES regarding clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital-based, full-service hospitals with capability of both PCI and CABG surgery in addition to cardiac catheterization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 19 years old\n* Left main disease, three-vessel disease or two-vessel disease with proximal LAD stenosis.\n\nExclusion Criteria:\n\n* Previous PCI within 1 year\n* Previous sternotomy\n* Primary PCI for STEMI\n* Contraindication or hypersensitivity to anti-platelet medications or contrast media\n* Planned need for concomitant other cardiac surgery (eg, valve surgery or resection of aortic or left ventricular aneurysm, etc)\n* Pregnant women or women with potential childbearing\n* Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator\n* Inability to understand or read the informed content'}, 'identificationModule': {'nctId': 'NCT02410993', 'briefTitle': 'Current Treatment Strategy of Patients With Multivessel Disease or Left Main Coronary Artery Disease Indicated for Coronary Artery Bypass Graft Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2015-0063'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CABG surgery', 'description': 'Candidates for CABG surgery for left main disease, three-vessel disease or two-vessel disease with proximal LAD stenosis indicated by current practice guideline', 'interventionNames': ['Procedure: CABG surgery']}], 'interventions': [{'name': 'CABG surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['CABG surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'MYEONG-KI HONG, MD', 'role': 'CONTACT', 'email': 'MKHONG61@yuhs.ac', 'phone': '82-2-2228-8458'}], 'facility': 'Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Myeong Ki Hong, MD, PhD', 'role': 'CONTACT', 'email': 'mkhong61@yuhs.ac', 'phone': '82-2-2228-8460'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}