Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-03 @ 2:20 PM
Study NCT ID:
NCT03594318
Status:
RECRUITING
Last Update Posted:
2018-07-20
First Post:
2018-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Versailles Hospital Cardiac Arrest Registry
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': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '24 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term favorable outcome', 'timeFrame': '1 year', 'description': 'A favorable outcome is defined by a Cerebral Performance Category scale score (CPC) of 1 or 2. The Cerebral Performance Category scale score will be determined according to hospital charts and/or general practitioner phone interview.\n\nThe CPC score : \\[5: Death, 4: Persistent vegetative state, 3: Severe disability, 2: Moderate disability, 1 : Low disability\\]'}], 'secondaryOutcomes': [{'measure': 'Short term favorable outcome', 'timeFrame': '3 months', 'description': 'A favorable outcome is defined by a Cerebral Performance Category scale score (CPC) of 1 or 2. The Cerebral Performance Category scale score will be determined according to hospital charts and/or general practitioner phone interview.\n\nThe CPC score : \\[5: Death, 4: Persistent vegetative state, 3: Severe disability, 2: Moderate disability, 1 : Low disability\\]'}, {'measure': 'Postanoxic Status Epilepticus', 'timeFrame': '28 days', 'description': 'Postanoxic Status Epilepticus occurence as defined by EEG abnormalities based on the Salzburg Criteria'}, {'measure': 'Complications of anticoagulant/ antiplatelet therapies', 'timeFrame': '28 days', 'description': 'Any bleeding requiring \\>2 Units Red Blood Cell transfusion'}, {'measure': 'Short term quality of life as assessed by the Short Form (36) Health Survey (SF36)', 'timeFrame': '3 months', 'description': 'Description of global SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).'}, {'measure': 'Long term quality of life as assessed by the Short Form (36) Health Survey (SF36)', 'timeFrame': '1 year', 'description': 'Description of global SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.\n\nData collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).\n\nOn-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and/or hospital/neurologist charts and/or general practitionner phone interview.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiac arrest requiring Intensive Care Unit Management', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac arrest requiring Intensive Care Unit management\n* Age \\>= 18 years\n\nExclusion Criteria:\n\n\\- Refusal to participate'}, 'identificationModule': {'nctId': 'NCT03594318', 'briefTitle': 'Versailles Hospital Cardiac Arrest Registry', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Hospital'}, 'officialTitle': 'Versailles Hospital Cardiac Arrest Registry', 'orgStudyIdInfo': {'id': 'P13/20_ACR'}}, 'contactsLocationsModule': {'locations': [{'city': 'Le Chesnay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Legriel Stephane, MD', 'role': 'CONTACT'}], 'facility': 'CH Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}], 'centralContacts': [{'name': 'Legriel Stephane, MD', 'role': 'CONTACT', 'email': 'slegriel@ch-versailles.fr'}], 'overallOfficials': [{'name': 'Legriel Stephane, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intensive care unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versailles Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'study principal investigator', 'investigatorFullName': 'LEGRIEL stephane', 'investigatorAffiliation': 'Versailles Hospital'}}}}