Social and Prognostic Inequalities in Patients Hospitalised for Cerebrovascular Accident (CVA) in Four Contrasting French Departments (INDIA)

December 26, 2018 updated by: Centre Hospitalier Universitaire Dijon

Social and Prognostic Inequalities in Patients Hospitalised for Cerebrovascular Accident (CVA) in Four Contrasting French Departments: Côte d'Or, Martinique, Guadeloupe and French Guyana Analysis of Their Impact on Vascular Risk Factors and the Management of CVA

This study should also raise questions about the interest and feasibility of establishing a permanent registry of CVA in the Antilles and Guyana. Indeed in coming decades, the expected doubling of the population of persons aged over 60 years and the foreseeable changes in lifestyle will increase the burden of this disease, in particular since the region is marked by a high prevalence of arterial hypertension and diabetes and a high level of precarity. In addition, this study will provide epidemiological information on CVA, its risk factors and management, which are non-existent for the department of French Guyana where the health environment is manifestly insufficient. These data should make it possible to better evaluate the resources available and the healthcare needs in Guyana.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1612

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Chu de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patient from CHU Dijon , CHU Point-à-Pitre and CHU Fort-de-France,CHU Guyane

Description

Inclusion Criteria:

  • Pre- inclusion
  • Patients who have received information about the study (directly or via a person of trust),
  • Patients aged more than 18 years,
  • Patient hospitalised for a suspected first symptomatic CVA (whatever the mechanism), preceded or not by a transient ischemic attack (TIA),
  • Patients with a cerebral imaging examination (CT-scan and/or MRI),
  • in Guyana, suspicion of a first CVA according to WHO clinical criteria and who died before the authorised images for descriptive purposes,
  • Patients able to answer questions personally or through a parent or a person of trust.

Definitive inclusion

- Patients with confirmed CVA diagnosed according to clinical criteria (WHO criteria) and imaging criteria.

Exclusion Criteria:

  • - Patients who refuse to take part in the study,
  • Patients with prior symptomatic CVA,
  • Patients without cerebral imaging (except in Guyana, for patients with suspected CVA who died before imaging),
  • Patients with another severe evolutive disease that could cause death in the weeks following the CVA,
  • Patients who cannot be contacted by telephone at 1 month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medical history
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Time Frame: Month 6
Month 6
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Time Frame: Month 1
Month 1
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bonithon PHRC N 2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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