Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-01-10 @ 1:22 AM
Study NCT ID:
NCT01239420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2010-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norwegian Cardio-Respiratory Arrest Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D003128', 'term': 'Coma'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, plasma, blood (PaxGene). For future identification of biochemical markers in prognostication after cardiorespiratory arrest. For future identification of biochemical markers for cardiac arrest (primarily serum, but also on mRNA-level).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest', 'Respiratory Arrest', 'Coma']}, 'referencesModule': {'references': [{'pmid': '31205786', 'type': 'DERIVED', 'citation': 'Beitland S, Nakstad ER, Berg JP, Troseid AS, Brusletto BS, Brunborg C, Lundqvist C, Sunde K. Urine beta-2-Microglobulin, Osteopontin, and Trefoil Factor 3 May Early Predict Acute Kidney Injury and Outcome after Cardiac Arrest. Crit Care Res Pract. 2019 May 7;2019:4384796. doi: 10.1155/2019/4384796. eCollection 2019.'}, {'pmid': '27716377', 'type': 'DERIVED', 'citation': 'Beitland S, Waldum-Grevbo BE, Nakstad ER, Berg JP, Troseid AS, Brusletto BS, Brunborg C, Andersen GO, Sunde K. Urine biomarkers give early prediction of acute kidney injury and outcome after out-of-hospital cardiac arrest. Crit Care. 2016 Oct 5;20(1):314. doi: 10.1186/s13054-016-1503-2.'}, {'pmid': '26453688', 'type': 'DERIVED', 'citation': 'Staer-Jensen H, Nakstad ER, Fossum E, Mangschau A, Eritsland J, Draegni T, Jacobsen D, Sunde K, Andersen GO. Post-Resuscitation ECG for Selection of Patients for Immediate Coronary Angiography in Out-of-Hospital Cardiac Arrest. Circ Cardiovasc Interv. 2015 Oct;8(10):e002784. doi: 10.1161/CIRCINTERVENTIONS.115.002784.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the use of combined clinical-neurological, neurophysiologic, neuroradiological and biochemical markers in prognostication after cardio- and/or respiratory arrest.', 'detailedDescription': 'Cardiac arrest (CA) is a leading cause of death, affecting about 700.000 individuals each year in Europe. Acute Myocardial Infarction (AMI) and primary arrhythmia are the most common causes of CA, whereas respiratory arrest is a leading cause of secondary CA. Patients who have undergone cardiopulmonary resuscitation (CPR) often remain unconscious after hospital admission, either as a result of severe permanent brain damage or a merely reversible metabolic disturbance due to post-ischemic global reperfusion. Early prediction of neurological and cardiac outcome remains a difficult task for physicians. The decision to continue, limit or terminate intensive care therapy carries huge ethical and socioeconomic implications. Optimal emergency cardiovascular care, cardiac failure therapy and CA prevention after hospitalisation also remain difficult issues for cardiologists and intensive care doctors.\n\nIn this prospective study running from 2010, both prognostication and in-hospital treatment are studied in a population of 261 patients with out-of-hospital cardio-respiratory arrest. The use of combined clinical-neurological, neurophysiologic, neuroradiological and biochemical markers is studied to asses whether a poor neurological outcome (Cerebral Performance Category 3-5) can be predicted with \\~100% specificity and a sensitivity that is sufficient for practical clinical use.\n\nPre-disposing and triggering causes of cardiorespiratory arrest are also registered. Patients with pre-existing conditions coherent with prophylactic ICD implementation under current international guidelines will be identified, in order to assess and further improve ICD-prophylactic treatment in Norway. The potential benefit of invasive PICCO-monitoring after CA will also be evaluated, and a subproject identifying biomarkers for CA risk has been established. NIRS (Near-Infrared spectroscopy) will also be used to register cerebral oxygenation in the early days after cardiorespiratory arrest.\n\nThe overall aim of the NORCAST study is to provide physicians with better tools to asses cardiac and neurological outcome as early and as accurate as possible.\n\nAll alive study patients are invited to long-term follow-up consultaions after 6 months, after 4 years, and after 10 years. The consultations will include study examinations, structured interviews and questionnaires. Questionnaires will also be used for next of kin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted after pre-hospital cardio/respiratory arrest.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prehospital cardial resuscitation\n* prehospital pulmonary resuscitation\n* ROSC before/on admission to hospital\n* \\> 18 years of age\n\nExclusion Criteria:\n\n* death on admission to hospital\n* arrhythmic cardiac arrest with ALS \\< 5min and spontaneous awakening\n* in-hospital cardiac arrest\n* trauma patients'}, 'identificationModule': {'nctId': 'NCT01239420', 'acronym': 'NORCAST', 'briefTitle': 'Norwegian Cardio-Respiratory Arrest Study', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Norwegian Cardio-Respiratory Arrest Study (NORCAST)', 'orgStudyIdInfo': {'id': 'REK S-O A Ref 2010/1116a'}}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital - Ulleval', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Dag Jacobsen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital - Ulleval, Norway'}, {'name': 'Kjetil Sunde, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital - Ulleval, Norway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Espen Rostrup Nakstad', 'investigatorAffiliation': 'Oslo University Hospital'}}}}