Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT00719667
Status:
COMPLETED
Last Update Posted:
2011-10-18
First Post:
2008-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
German Off Pump Coronary Artery Bypass in Elderly Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001026', 'term': 'Coronary Artery Bypass'}], 'ancestors': [{'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-17', 'studyFirstSubmitDate': '2008-07-20', 'studyFirstSubmitQcDate': '2008-07-21', 'lastUpdatePostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '1 month and 12 month'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 month and 12 month'}, {'measure': 'Stroke', 'timeFrame': '1 month and 12 month'}, {'measure': 'Any revascularisation', 'timeFrame': '1 month and30 month'}, {'measure': 'renal failure', 'timeFrame': '1 month and 12 month'}], 'secondaryOutcomes': [{'measure': 'ventilation time', 'timeFrame': 'post op'}, {'measure': 'blood transfusion', 'timeFrame': 'post op'}, {'measure': 'length of stay in intensive-care unit', 'timeFrame': 'post op'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OPCAB', 'coronary', 'bypass', 'grafting', 'off pump'], 'conditions': ['Heart Disease']}, 'referencesModule': {'references': [{'pmid': '30732456', 'type': 'DERIVED', 'citation': 'Diegeler A, Borgermann J, Kappert U, Hilker M, Doenst T, Boning A, Albert M, Farber G, Holzhey D, Conradi L, Riess FC, Veeckmann P, Minorics C, Zacher M, Reents W. Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients. Circulation. 2019 Apr 16;139(16):1865-1871. doi: 10.1161/CIRCULATIONAHA.118.035857.'}, {'pmid': '28854266', 'type': 'DERIVED', 'citation': 'Faerber G, Zacher M, Reents W, Boergermann J, Kappert U, Boening A, Diegeler A, Doenst T; GOPCABE investigators. Female sex is not a risk factor for post procedural mortality in coronary bypass surgery in the elderly: A secondary analysis of the GOPCABE trial. PLoS One. 2017 Aug 30;12(8):e0184038. doi: 10.1371/journal.pone.0184038. eCollection 2017.'}, {'pmid': '23477657', 'type': 'DERIVED', 'citation': 'Diegeler A, Borgermann J, Kappert U, Breuer M, Boning A, Ursulescu A, Rastan A, Holzhey D, Treede H, Riess FC, Veeckmann P, Asfoor A, Reents W, Zacher M, Hilker M; GOPCABE Study Group. Off-pump versus on-pump coronary-artery bypass grafting in elderly patients. N Engl J Med. 2013 Mar 28;368(13):1189-98. doi: 10.1056/NEJMoa1211666. Epub 2013 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old.\n\nHypothesis: The coronary bypass operation without use of the heart-lung machine (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary bypass operation (on-pump).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older or 75 years\n* indication for elective bypass operation\n* patient has signed written consent before randomization\n\nExclusion Criteria:\n\n* previous heart surgery\n* patient unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00719667', 'acronym': 'GOPCABE', 'briefTitle': 'German Off Pump Coronary Artery Bypass in Elderly Study', 'organization': {'class': 'NETWORK', 'fullName': 'German Off Pump Coronary Artery Bypass in Elderly Study Group'}, 'officialTitle': 'German Off Pump Coronary Artery Bypass in Elderly Study', 'orgStudyIdInfo': {'id': 'op 001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'coronary artery bypass grafting', 'type': 'OTHER', 'description': 'on pump off pump'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97616', 'city': 'Neustadt/Saale', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Herzchirurgie Neustadt/Saale'}, {'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universität Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Anno Diegeler, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzchirurgie Bad Neustadt/Saale'}, {'name': 'Michael Hilker, PD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universität Regensburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Off Pump Coronary Artery Bypass in Elderly Study Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Institut für Klinisch-Kardiovaskuläre Forschung GmbH', 'class': 'NETWORK'}, {'name': 'Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Hilker', 'investigatorFullName': 'PD Dr. Michael Hilker', 'investigatorAffiliation': 'German Off Pump Coronary Artery Bypass in Elderly Study Group'}}}}