- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04925869
Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours) (AVCBCT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Epidemiological 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.
We propose a prospective observational study based on the following hypothesis:
The 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Guiana
-
Cayenne, Guiana, French Guiana, 97306
- Centre Hospitalier de Cayenne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI
Exclusion Criteria:
- Age under 18 years
- Absence of MRI
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
The hospitals of Besançon
Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon
|
Observational study
|
|
the hospitals of Cayenne
Adult patients with MRI-confirmed CVA admitted to the hospitals of Cayenne.
|
Observational study
|
|
the hospitals of Tours
Adult patients with MRI-confirmed CVA admitted to the hospitals of Tours.
|
Observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence
Time Frame: 3 months
|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare the time required for treatment between Cayenne, Besançon and Tours in the event of an indication for thrombolysis
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bertrand De Toffol, PHD, Centre Hospitalier de Cayenne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVC BCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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