Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-27 @ 1:26 AM
Study NCT ID:
NCT01946932
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2013-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-04', 'studyFirstSubmitDate': '2013-09-12', 'studyFirstSubmitQcDate': '2013-09-17', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rivermead Behavioural Memory Test (RBMT)', 'timeFrame': '180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)', 'description': 'Memory test'}, {'measure': 'Frontal Assessment Battery (FAB)', 'timeFrame': '180 days after CA or MI', 'description': 'Screening of Executive functions'}, {'measure': 'Symbol Digit Modalities Test (SDMT)', 'timeFrame': '180 days after CA or MI', 'description': 'Assess attention, mental speed and concentration'}], 'secondaryOutcomes': [{'measure': 'Mayo-Portland Adaptability Inventory-4 (MPAI-4)', 'timeFrame': '180 days after CA or MI', 'description': 'Self rating of impairments, adjustment, and participation (in the society)'}, {'measure': 'Short-Form Questionnaire 36 version 2 (SF-36v2)', 'timeFrame': '180 days after CA or MI', 'description': 'Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver'}, {'measure': 'Zarit Burden Interview', 'timeFrame': '180 days after CA or MI', 'description': "Questionnaire for caregiver/informant/relative's perception of burden"}, {'measure': 'Hospital Anxiety and Depression rating Scale (HADS)', 'timeFrame': '180 days after CA or MI', 'description': 'Anxiety and Depression questionnaire'}, {'measure': 'Two Simple Questions (TSQ)', 'timeFrame': '180 days after CA or MI', 'description': 'Self rating of everyday activities and cognition'}, {'measure': 'Informant Questionnaire on Cognitive Decline (IQCODE)', 'timeFrame': '180 days after CA or MI', 'description': 'Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver'}, {'measure': 'MiniMental Status Examination (MMSE)', 'timeFrame': '180 days after CA or MI', 'description': 'General cognitive screening'}, {'measure': 'Cerebral Performance Category (CPC)', 'timeFrame': '180 days after CA or MI', 'description': 'Scale for general neurological outcome'}, {'measure': 'modified Rankin Scale', 'timeFrame': '180 days after CA or MI', 'description': 'Scale for general outcome'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Induced hypothermia', 'Mild induced hypothermia', 'Resuscitation', 'Therapeutic hypothermia', 'Neurological function', 'Cardiovascular diseases', 'Rehabilitation', 'Quality of life', 'Cognition'], 'conditions': ['Heart Arrest', 'Out-of-hospital Cardiac Arrest', 'Cognition Disorders', 'Brain Injury']}, 'referencesModule': {'references': [{'pmid': '19631442', 'type': 'BACKGROUND', 'citation': 'Cronberg T, Lilja G, Rundgren M, Friberg H, Widner H. Long-term neurological outcome after cardiac arrest and therapeutic hypothermia. Resuscitation. 2009 Oct;80(10):1119-23. doi: 10.1016/j.resuscitation.2009.06.021. Epub 2009 Jul 23.'}, {'pmid': '22520518', 'type': 'BACKGROUND', 'citation': 'Nielsen N, Wetterslev J, al-Subaie N, Andersson B, Bro-Jeppesen J, Bishop G, Brunetti I, Cranshaw J, Cronberg T, Edqvist K, Erlinge D, Gasche Y, Glover G, Hassager C, Horn J, Hovdenes J, Johnsson J, Kjaergaard J, Kuiper M, Langorgen J, Macken L, Martinell L, Martner P, Pellis T, Pelosi P, Petersen P, Persson S, Rundgren M, Saxena M, Svensson R, Stammet P, Thoren A, Unden J, Walden A, Wallskog J, Wanscher M, Wise MP, Wyon N, Aneman A, Friberg H. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design. Am Heart J. 2012 Apr;163(4):541-8. doi: 10.1016/j.ahj.2012.01.013.'}, {'pmid': '36164471', 'type': 'DERIVED', 'citation': 'Heimburg K, Cronberg T, Tornberg AB, Ullen S, Friberg H, Nielsen N, Hassager C, Horn J, Kjaergaard J, Kuiper M, Rylander C, Wise MP, Lilja G. Self-reported limitations in physical function are common 6 months after out-of-hospital cardiac arrest. Resusc Plus. 2022 Jul 19;11:100275. doi: 10.1016/j.resplu.2022.100275. eCollection 2022 Sep.'}, {'pmid': '29326145', 'type': 'DERIVED', 'citation': 'Lilja G, Nielsen N, Bro-Jeppesen J, Dunford H, Friberg H, Hofgren C, Horn J, Insorsi A, Kjaergaard J, Nilsson F, Pelosi P, Winters T, Wise MP, Cronberg T. Return to Work and Participation in Society After Out-of-Hospital Cardiac Arrest. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003566. doi: 10.1161/CIRCOUTCOMES.117.003566.'}, {'pmid': '26433116', 'type': 'DERIVED', 'citation': 'Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Ostman I, Cronberg T. Anxiety and depression among out-of-hospital cardiac arrest survivors. Resuscitation. 2015 Dec;97:68-75. doi: 10.1016/j.resuscitation.2015.09.389. Epub 2015 Oct 9.'}, {'pmid': '25681466', 'type': 'DERIVED', 'citation': 'Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Nilsson F, Pellis T, Wetterslev J, Wise MP, Bosch F, Bro-Jeppesen J, Brunetti I, Buratti AF, Hassager C, Hofgren C, Insorsi A, Kuiper M, Martini A, Palmer N, Rundgren M, Rylander C, van der Veen A, Wanscher M, Watkins H, Cronberg T. Cognitive function in survivors of out-of-hospital cardiac arrest after target temperature management at 33 degrees C versus 36 degrees C. Circulation. 2015 Apr 14;131(15):1340-9. doi: 10.1161/CIRCULATIONAHA.114.014414. Epub 2015 Feb 13.'}, {'pmid': '24118853', 'type': 'DERIVED', 'citation': 'Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Pellis T, Rundgren M, Wetterslev J, Wise MP, Nilsson F, Cronberg T. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial. BMC Cardiovasc Disord. 2013 Oct 12;13:85. doi: 10.1186/1471-2261-13-85.'}]}, 'descriptionModule': {'briefSummary': "This is a steering group approved substudy to the Target Temperature Management trial (TTM, ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest.\n\nThe primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction.\n\nOur secondary aims are:\n\n* To investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life.\n* To investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden.\n* To test the hypothesis that the simple cognitive screening battery used in the TTM main trial is sensitive enough to detect all patients with significant cognitive disability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause\n* Unconsciousness after sustained return of spontaneous circulation (ROSC)\n\nExclusion Criteria at time for inclusion in the TTM study:\n\n* Known bleeding diathesis\n* Suspected or confirmed acute intracranial bleeding\n* Suspected or confirmed stroke\n* Unwitnessed asystole\n* Known limitations in therapy and Do Not Resuscitate-order\n* Known disease making 180 days survival unlikely\n* Known prearrest status Cerebral Performance Category (CPC)3 or 4\n* Temperature \\<30°on admission\n\n * 4 hours (240 minutes) from ROSC to screening\n* Systolic blood pressure \\<80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump\n* In-hospital cardiac arrest\n* OHCA of presumed non-cardiac arrest cause\n\nAdditional Exclusion criteria for the sub-study:\n\n* Disability to speak the site language well enough to complete tests without interpreter\n* Controls should never have suffered a cardiac arrest'}, 'identificationModule': {'nctId': 'NCT01946932', 'briefTitle': 'Cognitive Impairment Following Cardiac Arrest and Target Temperature Management', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Cognitive Impairment Following Cardiac Arrest and Target Temperature Management', 'orgStudyIdInfo': {'id': 'TTMcogsub'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cardiac Arrest 33°', 'description': 'survivors with temperature treatment 33°', 'interventionNames': ['Other: Temperature treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cardiac Arrest survivors 36°', 'description': 'survivors with temperature treatment 36°', 'interventionNames': ['Other: Temperature treatment']}], 'interventions': [{'name': 'Temperature treatment', 'type': 'OTHER', 'armGroupLabels': ['Cardiac Arrest 33°', 'Cardiac Arrest survivors 36°']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'San Martino Hospital', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Pordenone', 'country': 'Italy', 'facility': 'Santa Maria degli Angeli Hospital', 'geoPoint': {'lat': 45.95689, 'lon': 12.66051}}, {'city': 'Trieste', 'country': 'Italy', 'facility': 'Ospedale Universitario di Cattinaria', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum (AMC)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Leeuwarden Hospital', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital, Thorax', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital, Östra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Helsingborg Hospital', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Karlstad', 'country': 'Sweden', 'facility': 'Karlstad Central Hospital', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Skåne University Hospital, Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skåne University Hospital, Malmö', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Örebro', 'country': 'Sweden', 'facility': 'Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St Georges' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Royal Berkshire NHS Foundation Trust', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Tobias Cronberg, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden'}, {'name': 'Niklas Nielsen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden'}, {'name': 'Jesper Kjaergaard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Heart Centrem Copenhagen University, Copenhagen, Denmark'}, {'name': 'Janneke Horn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Intensive Care, Academic Medical Centrum, Amsterdam, Netherlands'}, {'name': 'Tommaso Pellis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intensive Care Unit Santa Maria Degli Angeli, Pordenonde, Italy'}, {'name': 'Matthew P Wise, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, Untied Kingdom'}, {'name': 'Gisela Lilja, OT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lund University Hospital, Lund, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}, {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'Copenhagen University Hospital, Denmark', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliera Santa Maria Degli Angeli', 'class': 'OTHER'}, {'name': 'Copenhagen Trial Unit, Center for Clinical Intervention Research', 'class': 'OTHER'}, {'name': 'University Hospital of Wales', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}