AVCBCT: Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)

Sponsor
Centre Hospitalier de Cayenne (Other)
Overall Status
Completed
CT.gov ID
NCT04925869
Collaborator
Centre Hospitalier Régional Universitaire de Tours (Other), Centre Hospitalier Régional Universitaire, Besançon (Other)
300
1
10.8
27.8

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Other: Observational study

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 Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)
Actual Study Start Date :
May 7, 2019
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
The hospitals of Besançon

Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon

Other: Observational study
Observational study

the hospitals of Cayenne

Adult patients with MRI-confirmed CVA admitted to the hospitals of Cayenne.

Other: Observational study
Observational study

the hospitals of Tours

Adult patients with MRI-confirmed CVA admitted to the hospitals of Tours.

Other: Observational study
Observational study

Outcome Measures

Primary Outcome Measures

  1. Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence [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

Secondary Outcome Measures

  1. Compare the time required for treatment between Cayenne, Besançon and Tours in the event of an indication for thrombolysis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI
Exclusion Criteria:
  • Age under 18 years

  • Absence of MRI

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de Cayenne Cayenne Guiana French Guiana 97306

Sponsors and Collaborators

  • Centre Hospitalier de Cayenne
  • Centre Hospitalier Régional Universitaire de Tours
  • Centre Hospitalier Régional Universitaire, Besançon

Investigators

  • Principal Investigator: Bertrand De Toffol, PHD, Centre Hospitalier de Cayenne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier de Cayenne
ClinicalTrials.gov Identifier:
NCT04925869
Other Study ID Numbers:
  • AVC BCT
First Posted:
Jun 14, 2021
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2021