Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-28 @ 6:22 PM
Study NCT ID:
NCT00442494
Status:
TERMINATED
Last Update Posted:
2012-11-16
First Post:
2007-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-24', 'releaseDate': '2013-11-26'}, {'resetDate': '2018-11-01', 'releaseDate': '2018-03-05'}], 'estimatedResultsFirstSubmitDate': '2013-11-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study has been completed as planned', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-15', 'studyFirstSubmitDate': '2007-03-01', 'studyFirstSubmitQcDate': '2007-03-01', 'lastUpdatePostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Study couldn´t start due to investigator', 'timeFrame': 'Study couldn´t start due to investigator', 'description': 'Study couldn´t start due to investigator'}], 'primaryOutcomes': [{'measure': 'Study couldn´t start due to investigator', 'timeFrame': 'Study couldn´t start due to investigator', 'description': 'Study couldn´t start due to investigator'}], 'secondaryOutcomes': [{'measure': 'Study couldn´t start due to investigator', 'timeFrame': 'Study couldn´t start due to investigator', 'description': 'Study couldn´t start due to investigator'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation after cardiac surgery'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '17426276', 'type': 'DERIVED', 'citation': 'Voltarelli JC, Couri CE, Stracieri AB, Oliveira MC, Moraes DA, Pieroni F, Coutinho M, Malmegrim KC, Foss-Freitas MC, Simoes BP, Foss MC, Squiers E, Burt RK. Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2007 Apr 11;297(14):1568-76. doi: 10.1001/jama.297.14.1568.'}, {'pmid': '17426275', 'type': 'DERIVED', 'citation': 'Halonen J, Halonen P, Jarvinen O, Taskinen P, Auvinen T, Tarkka M, Hippelainen M, Juvonen T, Hartikainen J, Hakala T. Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial. JAMA. 2007 Apr 11;297(14):1562-7. doi: 10.1001/jama.297.14.1562.'}]}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery. Inflammatory response may be one etiological factor.\n\nWe hypothesized that intravenous corticosteroid administration after cardiac surgery prevents AF after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients scheduled to undergo their first on-pump CABG, aortic valve replacement or combined aortic valve replacement and CABG were enrolled.\n\nExclusion Criteria:\n\n* Previous episodes of AF or flutter\n* Uncontrolled diabetes mellitus\n* Systemic mycotic infection\n* Active tuberculosis\n* Cushing's syndrome\n* Psychotic mental disorder\n* Herpes Simplex keratitis\n* Serum creatinine exceeding 200 µg/ml\n* Patients were also excluded if they had a history of previous peptic ulcer or thrombophlebitis."}, 'identificationModule': {'nctId': 'NCT00442494', 'briefTitle': 'Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Feasibility of Corticosteroid in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Prospective, Double-Blind Randomized Multicenter Trial', 'orgStudyIdInfo': {'id': 'KUH5204515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study couldn´t start due to investigator', 'description': 'Study couldn´t start due to investigator', 'interventionNames': ['Drug: intravenous hydrocortisone']}], 'interventions': [{'name': 'intravenous hydrocortisone', 'type': 'DRUG', 'armGroupLabels': ['Study couldn´t start due to investigator']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jari Halonen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant', 'investigatorFullName': 'Helena Pehkonen', 'investigatorAffiliation': 'Kuopio University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-26', 'type': 'RELEASE'}, {'date': '2014-01-24', 'type': 'RESET'}, {'date': '2018-03-05', 'type': 'RELEASE'}, {'date': '2018-11-01', 'type': 'RESET'}], 'unpostedResponsibleParty': ', assistant, Kuopio University Hospital'}}}}