Clinical trial NCT04925869: Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)
Official title: Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accident
Thrombolysis
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Régional Universitaire de Tours
name: Centre Hospitalier Régional Universitaire, Besançon
First posted: 2021-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon, Cayenne, and Tours.

Brief summary: 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)

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.

Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI

Exclusion Criteria:

* Age under 18 years
* Absence of MRI

Primary outcomes:
measure: Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence
timeFrame: 3 months
Secondary outcomes:
measure: Compare the time required for treatment between Cayenne, Besançon and Tours in the event of an indication for thrombolysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: Centre Hospitalier de Cayenne
state: Guiana
Study officials:
affiliation: Centre Hospitalier de Cayenne
name: Bertrand De Toffol, PHD
role: PRINCIPAL_INVESTIGATOR
References: