Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 4:36 PM
Study NCT ID:
NCT00901134
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2009-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 452}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2009-05-12', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival and functional outcome (CPC: Cerebral Performance Categories)', 'timeFrame': 'after 3 months'}], 'secondaryOutcomes': [{'measure': 'Survival and/or functional outcome', 'timeFrame': 'after 24 hours'}, {'measure': 'Survival and/or functional outcome', 'timeFrame': 'after 7 days'}, {'measure': 'Survival and/or functional outcome', 'timeFrame': 'after one month'}, {'measure': 'Survival and/or functional outcome', 'timeFrame': 'at discharge'}, {'measure': 'Survival or functional outcome', 'timeFrame': 'after three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['therapeutic hypothermia after cardiac arrest'], 'conditions': ['Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '21471669', 'type': 'RESULT', 'citation': 'Yokoyama H, Nagao K, Hase M, Tahara Y, Hazui H, Arimoto H, Kashiwase K, Sawano H, Yasuga Y, Kuroda Y, Kasaoka S, Shirai S, Yonemoto N, Nonogi H; J-PULSE-Hypo Investigators. Impact of therapeutic hypothermia in the treatment of patients with out-of-hospital cardiac arrest from the J-PULSE-HYPO study registry. Circ J. 2011;75(5):1063-70. doi: 10.1253/circj.cj-11-0137. Epub 2011 Apr 7.'}, {'pmid': '22813874', 'type': 'DERIVED', 'citation': 'Soga T, Nagao K, Sawano H, Yokoyama H, Tahara Y, Hase M, Otani T, Shirai S, Hazui H, Arimoto H, Kashiwase K, Kasaoka S, Motomura T, Kuroda Y, Yasuga Y, Yonemoto N, Nonogi H; J-PULSE-Hypo Investigators. Neurological benefit of therapeutic hypothermia following return of spontaneous circulation for out-of-hospital non-shockable cardiac arrest. Circ J. 2012;76(11):2579-85. doi: 10.1253/circj.cj-12-0448. Epub 2012 Jul 20.'}], 'seeAlsoLinks': [{'url': 'http://j-pulse.umin.jp/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of cardiac arrest are advancing, however, survival rate is still very low in the world. Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is part of a standardized treatment strategy for comatose survivors of cardiac arrest in the metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the timing of initiation, the therapeutic windows and the rate for rewarming have not been defined clinically and should be established. The purpose of this research is the improvement in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac arrest using therapeutic hypothermia established from the analysis of multicenter registry data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with therapeutic hypothermia after cardiac arrest from 2005 to 2009 in each hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who remained unconscious after resuscitation from out-of-hospital or inhospital cardiac arrest\n* Presented the stable hemodynamics with drug treatments or mechanical supporting system including IABP or PCPS\n\nExclusion Criteria:\n\n* Patients with:\n\n * pregnancy\n * acute aortic dissection\n * pulmonary thromboembolism\n * drug poisoning\n * poor daily activity'}, 'identificationModule': {'nctId': 'NCT00901134', 'acronym': 'J-PULSE-HYPO', 'briefTitle': 'Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan', 'organization': {'class': 'OTHER', 'fullName': 'National Cerebral and Cardiovascular Center, Japan'}, 'officialTitle': 'Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan', 'orgStudyIdInfo': {'id': 'NCVC-JPULSE-H'}, 'secondaryIdInfos': [{'id': 'UMIN000001935'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'hypothermia', 'description': 'Patients with therapeutic hypothermia after cardiac arrest in hospitals'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima City Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Sapporo', 'state': 'Hokaido', 'country': 'Japan', 'facility': 'Sapporo City University Hopistal', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Kagawa University Hospital', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama City University Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka City General Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Police Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Sumitomo Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '565-8565', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Saiseikai Senri Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Mishima Emergency Critical Care Center', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'facility': 'Saga University Hospital', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nihon University Surugadai Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Ube', 'state': 'Yamaguchi', 'country': 'Japan', 'facility': 'Yamaguchi University Hospital', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}], 'overallOfficials': [{'name': 'Hiroshi Nonogi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, National Cardiovascular Center , Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cerebral and Cardiovascular Center, Japan', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hiroshi Nonogi', 'oldOrganization': 'Department of Cardiology , National Cardiovascular Center,Japan'}}}}