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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04489199
Other study ID # BEJOT 2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 2040

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire Dijon
Contact Yannick BEJOT
Phone 03.80.29.37.53
Email yannick.bejo@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Dijon Stroke Registry, accredited by the Registry Evaluation Committee, INSERM and Public Health France, has been studying the epidemiology of cerebrovascular accidents (cerebral infarction, intracerebral haemorrhages, meningeal haemorrhages) and transient ischaemic attacks (TIAs) within the city of Dijon since 1985. As a result of the development of therapies for acute disease, the prognosis of patients has improved over time. Thus, the number of stroke survivors has increased by 90% between the 1980s and today. This raises new issues: risk of vascular recurrence, drug iatrogeny, and functional impact of stroke for motor, cognitive or thymic function. In the absence of available data in France, the investigators wish to set up an extended cohort follow-up of patients in order to study their long-term prognosis and to study the impact of future therapies on the evolutionary course of the disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date January 2040
Est. primary completion date January 2040
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients included in the Dijon Stroke Registry and not opposed to participating Exclusion Criteria: - minor patients; opposition to participation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire and semi-structured interview
questionnaire submitted by telephone 3 months, 6 months, 1 year, 5 years, and 10 years after the stroke/TIA. interview duration 20 to 40 minutes

Locations

Country Name City State
France Chu Dijon Bourgogne 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 Death rate Trough study completion, an average of 10 years
Primary Disability rate Trough study completion, an average of 10 years
Primary Quality of Life Questionnaire Trough study completion, an average of 10 years
Primary Neuropsychological questionnaire Trough study completion, an average of 10 years