Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-28 @ 4:52 PM
Study NCT ID:
NCT00953368
Status:
UNKNOWN
Last Update Posted:
2009-08-06
First Post:
2009-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-05', 'studyFirstSubmitDate': '2009-08-05', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive function', 'timeFrame': 'preoperative, 1 week and 6 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['remote ischemic preconditioning', 'cognitive function', 'off-pump coronary artery bypass graft'], 'conditions': ['Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '11903027', 'type': 'BACKGROUND', 'citation': 'Van Dijk D, Jansen EW, Hijman R, Nierich AP, Diephuis JC, Moons KG, Lahpor JR, Borst C, Keizer AM, Nathoe HM, Grobbee DE, De Jaegere PP, Kalkman CJ; Octopus Study Group. Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a randomized trial. JAMA. 2002 Mar 20;287(11):1405-12. doi: 10.1001/jama.287.11.1405.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective off-pump coronary artery bypass graft surgery\n\nExclusion Criteria:\n\n* Emergency operation\n* Preoperative use of inotropic drugs or mechanical assistant device\n* Ejection fraction less than 30%\n* Combined operation using CPB such as valve surgery\n* Previous psychiatric and neurologic disorder\n* Inability to perform the cognitive function test'}, 'identificationModule': {'nctId': 'NCT00953368', 'briefTitle': 'Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft', 'orgStudyIdInfo': {'id': 'RIPC-3862'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remote ischemic preconditioning', 'description': 'Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis', 'interventionNames': ['Procedure: remote ischemic preconditioning']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'sham placement of a blood-pressure cuff around the upper limb without inflation', 'interventionNames': ['Procedure: remote ischemic preconditioning']}], 'interventions': [{'name': 'remote ischemic preconditioning', 'type': 'PROCEDURE', 'description': 'Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis', 'armGroupLabels': ['Remote ischemic preconditioning', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'In-Cheol Choi, professor', 'role': 'CONTACT', 'email': 'icchoi@amc.seoul.kr', 'phone': '+82-2-3010-3862'}, {'name': 'Dae-Kee Choi, fellow', 'role': 'CONTACT', 'email': 'd001109@hanmail.net', 'phone': '+82-2-3010-5633'}], 'facility': 'Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'In-Cheol Choi, professor', 'role': 'CONTACT', 'email': 'icchoi@amc.seoul.kr', 'phone': '+82-2-3010-3862'}, {'name': 'Dae-Kee Choi, fellow', 'role': 'CONTACT', 'email': 'd001109@hanmail.net', 'phone': '+82-2-3010-5633'}], 'overallOfficials': [{'name': 'In-Cheol Choi, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center, Department of Anesthesiology and Pain Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'In-Cheol Choi, professor', 'oldOrganization': 'Asan Medical Center, Department of Anesthesiology and Pain Medicine'}}}}