Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT06569134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest (MIRA29)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-01-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Outcome', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months', 'description': 'It will be evaluated at the end of the ICU stay using the CPC score; a CPC score equal or below 2 will be considered as a good outcome, while a CPC \\> 2 will be considered as a bad outcome'}], 'secondaryOutcomes': [{'measure': 'Death OoH', 'timeFrame': 'Before hospital arrival', 'description': 'Death after resuscitation during the prehospital care phase'}, {'measure': 'Death ICU', 'timeFrame': 'During ICU stay', 'description': 'Death within the ICU care'}, {'measure': 'Death at Day 28', 'timeFrame': '28 days after cardiac arrest', 'description': 'Death at Day 28, before or after hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest', 'Neurologic Dysfunction', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "From the informatized prehospital care registry, data will be collected anonymously for all patients' requiring cardiopulmonary resuscitation for an out-of-hospital cardiac arrest within the Norther Finistere sanitary region.\n\nFirst step of the model derivation will consist in multivariate analysis to extract the most pertinent variates associated with neurological outcome (evaluated using the CPC Score); Second step will consist in the use of artificial intelligence and machine-learning to derive the most discriminant score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting a cardiac arrest requiring cardiopulmonary resuscitation, taken in charge by the Northern Finistere Prehospital Care System, will be included Datafiles will be individually revised', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac arrest requiring cardiopulmonary resuscitation\n\nExclusion Criteria:\n\n* Death before cardiopulmonary resuscitation\n* Pediatric Patients'}, 'identificationModule': {'nctId': 'NCT06569134', 'acronym': 'MIRA29', 'briefTitle': 'Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest (MIRA29)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest in the North Finistère Population: Derivation and Validation of a Predictive Score', 'orgStudyIdInfo': {'id': '29BRC22.0114 - MIRA29'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29600', 'city': 'Morlaix', 'country': 'France', 'facility': 'CH des pays de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}