Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01321918
Status:
TERMINATED
Last Update Posted:
2011-03-24
First Post:
2011-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'whyStopped': 'Recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-23', 'studyFirstSubmitDate': '2011-03-23', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of variants in DNA', 'description': 'The primary endpoint is the identification of variants (polymorphisms and / or mutations) in DNA significantly associated with risk of extra-hospital sudden death in adults. Study populations are : (i) the entire population of case subjects included in the DNA bank (ii) two subpopulations at high risk of sudden death : patients with a history of myocardial infarction and patients with LVEF \\< 30 %. The variable analyzed is the nucleotide sequence of DNA in populations of case and control subjects.'}], 'secondaryOutcomes': [{'measure': 'Annual incidence of extra-hospital sudden death in adults', 'description': 'The annual incidence of extra-hospital sudden death in adults. The variable analyzed is the number of incident cases per year of extra-hospital sudden death in adults.'}, {'measure': 'Annual mortality related to extra-hospital sudden death in adults', 'description': 'The annual mortality related to extra-hospital sudden death in adults. The variable analyzed is the number of annual deaths due to sudden death in adults.'}, {'measure': 'Characterization of victims of extra-hospital sudden death in adults', 'description': 'The characterization of victims of extra-hospital sudden death in adults, their medical care in emergency and their future from D0 to D28. Variables analyzed are clinical data are collected in case report forms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Extra-hospital Sudden Death']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is the formation of a DNA bank to realise a case-control genetic study designed to identify sequence variations in DNA that predispose to sudden cardiac death in adults.\n\nThe secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA :\n\n* Inclusion criteria for register :\n* Adults ≥ 18 years of age.\n* Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.\n* Patients not hospitalized at the time of sudden death.\n* Inclusion criteria for DNA bank :\n* Case subjects :\n* Adults ≥ 18 years of age.\n* Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.\n* Patients not hospitalized at the time of sudden death.\n* Patients supported clinically by an emergency ambulance service.\n* Control subjects :\n* Adults ≥ 18 years of age.\n* Adults hospitalized in an cardiac intensive care unit.\n\nEXCLUSION CRITERIA :\n\n* Exclusion criteria for register :\n* Violent death : criminal, suicidal or accidental.\n* Exclusion criteria for DNA bank :\n* Case subjects :\n* Violent death : criminal, suicidal or accidental.\n* Identified cause of death extra-cardiac : neurological cause, hypoxia, pulmonary embolism, aortic rupture or other identified extra-cardiac cause.\n* In accordance with Articles L1221-5 L1221-L1221-8 and 8-1 of the Code of Public Health, the categories of persons are excluded from research due to the fact that it can be achieved with an efficiency comparable over another class of people :\n* Adult subject to legal protection measure,\n* Pregnant woman,\n* Parturient,\n* Breastfeeding mother,\n* Person deprived of liberty,\n* Person hospitalised without his consent,\n* Person admitted to a medical or socially facility.\n* Control subjects :\n* History of sudden death,\n* Documented history of ventricular fibrillation,\n* History of sustained ventricular tachycardia (lasting longer than 30 seconds) documented.'}, 'identificationModule': {'nctId': 'NCT01321918', 'briefTitle': 'Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Register and DNA Bank of Adult Extra-hospital Sudden Death', 'orgStudyIdInfo': {'id': '06/6-A'}, 'secondaryIdInfos': [{'id': '2006-A00544-47', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Case subjects', 'interventionNames': ['Other: Case Controls']}, {'type': 'OTHER', 'label': 'Control subjects', 'interventionNames': ['Other: Control subjects']}], 'interventions': [{'name': 'Case Controls', 'type': 'OTHER', 'description': 'A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised on a route of vascular development place in the context of medical practice.Clinical data will be indicated in the CRF and the computerized database. In the event an eligible patient has not been included during his support by an emergency ambulance service but, after successful resuscitation, he has been hospitalised in a cardiology department, its inclusion may be realised during the hospitalization by a physician investigator of the study. A blood sample of 10 ml of 2 EDTA tubes will be realised on a route of vascular development in the context of routine care.', 'armGroupLabels': ['Case subjects']}, {'name': 'Control subjects', 'type': 'OTHER', 'description': 'A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised and clinical data will be indicated in the CRF and the computerized database.', 'armGroupLabels': ['Control subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Vincent PROBST, Profesor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Jean-Luc CHASSEVENT, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Angers'}, {'name': 'Nicolas HOURDIN, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'CH de Châteaubriant'}, {'name': 'Yves-Marie PLUCHON, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'CH de la Roche-sur-Yon'}, {'name': 'Christophe SAVIO, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'CH du Mans'}, {'name': 'Jean-Pierre AUFFRAY, Profesor', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU de Marseille'}, {'name': 'Christian HAMON, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'CH de Saint-Brieuc'}, {'name': 'Christophe BERRANGER, Profesor', 'role': 'STUDY_CHAIR', 'affiliation': 'CH de Saint-Nazaire'}, {'name': 'Jean-Louis DUCASSE, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Toulouse'}, {'name': 'BOULANGER, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'CH de Vannes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Anne OMNES', 'oldOrganization': 'Nantes University Hospital'}}}}