Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT03770520
Status:
UNKNOWN
Last Update Posted:
2018-12-11
First Post:
2018-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'QFR will be masked to care providers and participants, and open to investigators, the allocation will be based on QFR.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-09', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of graft patency', 'timeFrame': '12 months', 'description': 'graft patency will be evaluated by CTA, 2 doctors will be invited to read the CT and draw their own conclusion without knowing the other result'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular event(MACE)', 'timeFrame': '12 months', 'description': 'The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization'}, {'measure': 'The rate of angina relief', 'timeFrame': '12 months', 'description': 'whether angina is relieved will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quantitative Flow Ratio', 'Coronary Artery Bypass Grafting', 'Graft patency'], 'conditions': ['Coronary Artery Disease', 'Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.', 'detailedDescription': 'CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with evidence of angina pectoris\n* left main or three vessels disease, have the indication for CABG after discussion of the heart team\n* at least one main vessels stenosis on 40%-70%\n\nExclusion Criteria:\n\n* former cardiac surgery patients\n* need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy\n* emergent CABG\n* acute myocardial infarction time less than 7 days\n* life expectancy less than 3 years'}, 'identificationModule': {'nctId': 'NCT03770520', 'briefTitle': 'Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Z171100001017059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QFR-guided', 'description': 'This group will be performed a CABG surgery based on CAG and QFR, whether graft the moderate stenosis vessels will be based on the result of QFR.', 'interventionNames': ['Procedure: QFR-guided CABG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Angio-guided', 'description': 'This group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team.', 'interventionNames': ['Procedure: Angio-guided CABG']}], 'interventions': [{'name': 'QFR-guided CABG', 'type': 'PROCEDURE', 'description': 'CABG surgery based on CAG and QFR', 'armGroupLabels': ['QFR-guided']}, {'name': 'Angio-guided CABG', 'type': 'PROCEDURE', 'description': 'CABG surgery based on heart team discussion of CAG', 'armGroupLabels': ['Angio-guided']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Zhao, MD', 'role': 'CONTACT', 'email': 'allen_hya731@sohu.com', 'phone': '86-10-64456411'}, {'name': 'Ran Dong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yang Zhao, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yang Zhao, MD', 'role': 'CONTACT', 'email': 'allen_hya731@sohu.com', 'phone': '13810050821'}], 'overallOfficials': [{'name': 'Ran Dong, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Municipal Science & Technology Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Direcotr,chief of ward No.11, Department of cardiac surgery', 'investigatorFullName': 'Dong Ran', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}