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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04925869
Other study ID # AVC BCT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 7, 2019
Est. completion date March 31, 2020

Study information

Verified date June 2021
Source Centre Hospitalier de Cayenne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI Exclusion Criteria: - Age under 18 years - Absence of MRI

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational study
Observational study

Locations

Country Name City State
French Guiana Centre Hospitalier de Cayenne Cayenne Guiana

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier de Cayenne Centre Hospitalier Régional Universitaire de Tours, Centre Hospitalier Régional Universitaire, Besançon

Country where clinical trial is conducted

French Guiana, 

Outcome

Type Measure Description Time frame Safety issue
Primary Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence 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 Compare the time required for treatment between Cayenne, Besançon and Tours in the event of an indication for thrombolysis 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
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