Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04925869
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2021-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence', 'timeFrame': '3 months', 'description': 'Clinical assessment of stroke (NIHSS score) and systematic collection of vascular risk factors (diabetes, hypertension, dyslipidemia, emboligic heart disease) Suspected mechanism (TOAST). Modified Rankin score'}], 'secondaryOutcomes': [{'measure': 'Compare the time required for treatment between Cayenne, Besançon and Tours in the event of an indication for thrombolysis', 'timeFrame': '3 months', 'description': 'Time to access care and management. The following will be specified: the time between the onset of symptoms and admission, MRI, and thrombolysis, if applicable.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Accident', 'Thrombolysis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to specify the typology of CVA in French Guiana by prospectively comparing consecutive strokes observed at each of the three study sites (Cayenne, Tours, Besançon)', 'detailedDescription': 'CVA is a public health problem that is managed in a codified manner by the Neurovascular Units (NU). In Cayenne, in the absence of a NU, strokes are managed directly in the emergency room by 24-hour telemedicine provided by the neurovascular team at the Besançon University Hospital. The vascular neurologist can perform a clinical examination remotely in a dedicated examination room and has access to magnetic resonance imaging by image transfer. The Tours and Besançon university hospitals each have a regional reference NU. The coordinating investigator of the study is the head of the neurology department of the Tours University Hospital, currently on an extended mission in Cayenne. The initial emergency management of a person with stroke who is hospitalized is comparable between the three regions studied.\n\nEpidemiological studies show disparities in stroke mortality and vascular risk factors between French regions. The stroke mortality rate in French Guiana in 2013 (72 per 100 000 population per year) was twice that of metropolitan France. The standardized prevalence rate of diabetes in French Guiana is 7.1% of the population compared with 4.4% in metropolitan France, and the prevalence of hypertension is twice as high among women in the French Guiana West Indies compared with metropolitan France. There are twice as many obese persons (BMI\\>30) in Guyanese women compared with metropolitan France.\n\nWe propose a prospective observational study based on the following hypothesis:\n\nThe average age of stroke occurrence, its type (ischemic or hemorrhagic), the vascular territories involved, the vascular risk factors, and the pre-hospital and intra-hospital management times will be superimposable between two metropolitan regions but different in French Guyana.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon, Cayenne, and Tours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI\n\nExclusion Criteria:\n\n* Age under 18 years\n* Absence of MRI'}, 'identificationModule': {'nctId': 'NCT04925869', 'acronym': 'AVCBCT', 'briefTitle': 'Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Cayenne'}, 'officialTitle': 'Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)', 'orgStudyIdInfo': {'id': 'AVC BCT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The hospitals of Besançon', 'description': 'Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon', 'interventionNames': ['Other: Observational study']}, {'label': 'the hospitals of Cayenne', 'description': 'Adult patients with MRI-confirmed CVA admitted to the hospitals of Cayenne.', 'interventionNames': ['Other: Observational study']}, {'label': 'the hospitals of Tours', 'description': 'Adult patients with MRI-confirmed CVA admitted to the hospitals of Tours.', 'interventionNames': ['Other: Observational study']}], 'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'Observational study', 'armGroupLabels': ['The hospitals of Besançon', 'the hospitals of Cayenne', 'the hospitals of Tours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97306', 'city': 'Cayenne', 'state': 'Guiana', 'country': 'French Guiana', 'facility': 'Centre Hospitalier de Cayenne', 'geoPoint': {'lat': 4.9381, 'lon': -52.33455}}], 'overallOfficials': [{'name': 'Bertrand De Toffol, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier de Cayenne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Cayenne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Régional Universitaire de Tours', 'class': 'OTHER_GOV'}, {'name': 'Centre Hospitalier Régional Universitaire, Besançon', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}