CVA, Dijon RegistryDISCONCT04489199
Dijon Stroke Cohort
An observational study of CVA, Dijon Registry, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA, Dijon Registry
- What is being tested?
- Questionnaire and semi-structured interview
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to Jan 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in the Dijon Stroke Registry
Who may be able to join
- patients included in the Dijon Stroke Registry and not opposed to participating
Who cannot join
- minor patients; opposition to participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Yannick BEJOT, 03.80.29.37.53 ext. +33, yannick.bejo@chu-dijon.fr
About this study
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.
- Conditions
- CVA, Dijon Registry
- Being tested
- Questionnaire and semi-structured interview
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and semi-structured interviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| Stroke patient | Patient included in the Dijon Stroke Registry. Receives: Other: Questionnaire and semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rate
Measured: Trough study completion, an average of 10 years
Disability rate
Measured: Trough study completion, an average of 10 years
Quality of Life Questionnaire
Measured: Trough study completion, an average of 10 years
Neuropsychological questionnaire
Measured: Trough study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Jan 2021
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVA, Dijon RegistryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489199
- Sponsor's protocol ID
- BEJOT 2020
- Acronym
- DISCO
- Status last verified
- Feb 2024
- First submitted
- 16 Jul 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dijon Stroke Cohort
- ClinicalTrials.gov ID
- NCT04489199
- Acronym / sponsor ID
- DISCO / BEJOT 2020
- Conditions
- CVA, Dijon Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patient | – | Other: Questionnaire and semi-structured interviewPatient included in the Dijon Stroke Registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the Dijon Stroke Registry
Key inclusion criteria (1 listed)
- patients included in the Dijon Stroke Registry and not opposed to participating
Key exclusion criteria (1 listed)
- minor patients; opposition to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and semi-structured interviewquestionnaire submitted by telephone 3 months, 6 months, 1 year, 5 years, and 10 years after the stroke/TIA. interview duration 20 to 40 minutes | Other | Stroke patient |
Primary outcome
Death rate
Time frame: Trough study completion, an average of 10 years
Disability rate
Time frame: Trough study completion, an average of 10 years
Quality of Life Questionnaire
Time frame: Trough study completion, an average of 10 years
Neuropsychological questionnaire
Time frame: Trough study completion, an average of 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CVA, Dijon Registry, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannick BEJOT (03.80.29.37.53 ext. +33, yannick.bejo@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death rate (time frame: Trough study completion, an average of 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.