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

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)

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Accident; Thrombolysis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• French Guiana
  • Guiana
    • Cayenne, Guiana, French Guiana, 97306
      • Centre Hospitalier de Cayenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon, Cayenne, and Tours.

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?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

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	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 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: Centre Hospitalier de Cayenne
• Collaborators: Centre Hospitalier Régional Universitaire de Tours; Centre Hospitalier Régional Universitaire, Besançon
• Investigators: Principal Investigator: Bertrand De Toffol, PHD, Centre Hospitalier de Cayenne

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: AVC BCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No