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

Symptomatic CVA (de Novo CVA) Clinical Trial

— INDIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906463
• Other study ID #: bonithon PHRC N 2010
• Status: Completed
• Start date: July 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1612
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Symptomatic CVA (de Novo CVA)

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical history		Baseline
Secondary	Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status		Month 6
Secondary	Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status		Month 1
Secondary	Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status		Month 12