Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00259493
Status:
UNKNOWN
Last Update Posted:
2006-09-11
First Post:
2005-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2007-10'}, 'lastUpdateSubmitDate': '2006-09-07', 'studyFirstSubmitDate': '2005-11-25', 'studyFirstSubmitQcDate': '2005-11-25', 'lastUpdatePostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery'}], 'secondaryOutcomes': [{'measure': 'Length of Hospital Stay'}, {'measure': 'Blood Loss'}, {'measure': 'Operative Time'}, {'measure': 'Post-op Complications'}, {'measure': 'Quality of Life Assessment'}]}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Coronary Artery Bypass Graft Surgery', 'Off-pump CABG', 'Cardiac CT', 'Bypass Graft CT angiography'], 'conditions': ['Coronary Artery Disease Amenable to Bypass Graft Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare graft patency rates following coronary artery bypass graft surgery performed by beating heart vs. conventional techniques using cardiac CT scanning to evaluate the bypass grafts.', 'detailedDescription': 'The issue of whether to perform conventional CABG or off-pump CABG continues to be the subject of debate. Controversy remains regarding the appropriateness of applying OPCAB to all patients as opposed to selected sub-populations.\n\nThe main strategy of CABG is to obtain complete revascularization with the least morbidity and highest long-term patency rates. Current medical literature is conflicted regarding graft patency rates in OPCAB vs. conventional CABG. Data is also limited due to patient refusal for conventional angiography to assess grafts following surgery. Cardiac computed tomography (CT) offers a non-invasive method to assess graft patency that is 100% accurate for the diagnosis of graft patency vs. occlusion. This study is a prospective randomized controlled trial evaluating graft patency in on-pump vs. off-pump CABG using cardiac CT scanning. The study hypothesis is that graft patency rates will be equivalent between the two techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgery indicated\n* Patient is hemodynamically stable\n* Isolated coronary artery surgery (no valve)\n* No contraindications to cardiopulmonary bypass\n* No previous surgery (not redo CABG)\n\nExclusion Criteria:\n\n* critically ill patient with hemodynamic instability.\n* concomitant cardiac procedures.\n* inability to provide written informed consent.\n* prior severe reaction to contrast dye :\n* life-threatening anaphylactoid reactions\n* cardiac dysrhythmias and arrest\n* cardiovascular and pulmonary collapse\n* elevated serum creatinine (\\>150 mmol/L).\n* contraindications to cardiopulmonary bypass.\n* Age \\< 18 years .'}, 'identificationModule': {'nctId': 'NCT00259493', 'briefTitle': 'Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT', 'organization': {'class': 'OTHER', 'fullName': 'Trillium Health Centre'}, 'officialTitle': 'Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Off-Pump Coronary Artery Bypass Graft Surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L5B 1B8', 'city': 'Mississauga', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Trillium Health Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'centralContacts': [{'name': 'Kathy Ariss, BSc, RN', 'role': 'CONTACT', 'email': 'kariss@thc.on.ca', 'phone': '416-400-4753'}], 'overallOfficials': [{'name': 'Tarang N Sheth, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trillium Health Centre'}, {'name': 'Gopal Bhatnagar, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trillium Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trillium Health Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Toshiba America Medical Systems, Inc.', 'class': 'INDUSTRY'}]}}}