Cerebral (CVAs)BRESTNCT02900521
Population-based Brest Stroke Registry
An observational study of Cerebral (CVAs) and Ischemic Cerebrovascular Accident, run by University Hospital, Brest at 1 site in France.
Trial summary
The registry is the main objective exhaustive list of cases validated stroke brain on a geographical area defined to calculate an incidence. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cerebral (CVAs), Ischemic Cerebrovascular Accident, Stroke
- How many people
- 15,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Dec 2026
- How long will I take part?
- 10 Years
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diagnostic validated for one of the following pathologies: * Ischemic stroke, * Non-traumatic intracranial hematoma * Cerebral venous thrombosis Diagnostic after December 31, 2007 Age > 15 years on the date of the diagnostic Patient domiciled at the time of the diagnostic in one of the 79 communes defined beforehand
Who may be able to join
- Diagnostic validated for one of the following pathologies:
- Ischemic stroke,
- Non-traumatic intracranial hematoma
- Cerebral venous thrombosis Diagnostic after December 31, 2007 Age > 15 years on the date of the diagnostic Patient domiciled at the time of the diagnostic in one of the 79 communes defined beforehand
Who cannot join
- Age ≤ 15 years
- Validated diagnosis (see below, § 4.2.2) of aneurysmal subarachnoid hemorrhage cerebrovascular
- Diagnosis made before 1 January 2008
- Unconfirmed diagnosis
- Patient domiciled outside the previously defined area of residence
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
CHRU de Brest
Brest, 29200
Serge TIMSIT, +33298347620, serge.timsit@chu-brest.fr
Francois ROUHART
About this study
Official title: The Brest Registry of Stroke
The registry is the main objective exhaustive list of cases validated stroke brain on a geographical area defined to calculate an incidence.
Read the detailed description
The main objective of Brest Stroke Registry is to regroup all confirmed cases of stroke over a defined geographical zone in order to calculate an incidence.
There are three prospective medium-term goals:
- In respect with public health epidemiology:
- To obtain incidence data and evaluate the regional and international divergences
- To obtain the mortality data in short and long term. Since the onset of the registry, it has been implemented a study on the mortality of stroke patients of Brest Registry. This study has been realized independently for both types of stroke, i.e. ischemic and hemorrhagic, with different caused mortality. This mortality was studied at medium-term (≤ 28 days) as well as at long-term (> 28 days). There will be a collaboration project between Public Health Surveillance (InVS), Brest University Hospital and Rennes network on all causes of death.
- Pharmaco-epidemiology
In clinical terms, the registry offers an opportunity to do an inventory of all current practices (diagnosis, therapies and the subsidiaries) and propose in this manner the best management of stroke. This strategy is in line with the pilot programs deployed by the French High Health Authority (HAS) for improvement of quality and safety of the health care. The bleeding risk associated with anticoagulants and anti-platelet agents in people of Brest as well as that of Dijon and Lille (in collaboration with their respective registry) will be analyzed.
This study has gained a particular characteristic since 2012 with emerging new oral anticoagulants (OAC) which have shown less associated bleeding risks compared with vitamin K antagonists (randomized controlled trials).
•In terms of clinical research :
- Study the impacted consequences of stroke by socio-economic characteristics of the territories in the Pays de Brest
- Identify short and long term clinical predictors of mortality in patients who have had a hemorrhagic stroke.
- To identify clinical predictors of mortality in the short and long-term patients with ischemic stroke.
- To identify genetic predictors of mortality and long-term recurrence of patients with ischemic stroke
- Identify stroke identification algorithm from existing databases
- Conditions
- Cerebral (CVAs), Ischemic Cerebrovascular Accident, Stroke, Brain Ischemia, Brain Hemorrhage, Ischemic Stroke
- Medical subject headings
- Ischemic Stroke, Stroke, Brain Ischemia, Intracranial Hemorrhages, Hemorrhagic Stroke, Cerebrovascular Disorders, Ischemic Attack, Transient
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of stroke (ischemic or haemorrhagic)
The type of stroke ischemic or haemorrhagic will be collected from physician diagnostic
Measured: Inclusion
Secondary outcomes (1)
Patient outcome
Patient outcome (mortality) wanted by mail from towns of birth
Measured: Every year after the inclusion during 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2008
- Primary completionAug 2016
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral (CVAs)Studies 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
- 15,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Santé publique France-InVS (Institut National de Veille sanitaire), Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Serge TIMSIT, Principal investigator, CHRU La Cavale Blanche - BREST - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900521
- Sponsor's protocol ID
- REGISTRE AVC
- Acronym
- BREST
- Status last verified
- May 2023
- First submitted
- 22 Aug 2016
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brest Registry of Stroke
- ClinicalTrials.gov ID
- NCT02900521
- Acronym / sponsor ID
- BREST / REGISTRE AVC
- Conditions
- Cerebral (CVAs), Ischemic Cerebrovascular Accident, Stroke, Brain Ischemia, Brain Hemorrhage, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Santé publique France-InVS (Institut National de Veille sanitaire), Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jan 2008 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- 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 registry is the main objective exhaustive list of cases validated stroke brain on a geographical area defined to calculate an incidence.
Detailed description
The main objective of Brest Stroke Registry is to regroup all confirmed cases of stroke over a defined geographical zone in order to calculate an incidence.
There are three prospective medium-term goals:
- In respect with public health epidemiology:
- To obtain incidence data and evaluate the regional and international divergences
- To obtain the mortality data in short and long term. Since the onset of the registry, it has been implemented a study on the mortality of stroke patients of Brest Registry. This study has been realized independently for both types of stroke, i.e. ischemic and hemorrhagic, with different caused mortality. This mortality was studied at medium-term (≤ 28 days) as well as at long-term (> 28 days). There will be a collaboration project between Public Health Surveillance (InVS), Brest University Hospital and Rennes network on all causes of death.
- Pharmaco-epidemiology
In clinical terms, the registry offers an opportunity to do an inventory of all current practices (diagnosis, therapies and the subsidiaries) and propose in this manner the best management of stroke. This strategy is in line with the pilot programs deployed by the French High Health Authority (HAS) for improvement of quality and safety of the health care. The bleeding risk associated with anticoagulants and anti-platelet agents in people of Brest as well as that of Dijon and Lille (in collaboration with their respective registry) will be analyzed.
This study has gained a particular characteristic since 2012 with emerging new oral anticoagulants (OAC) which have shown less associated bleeding risks compared with vitamin K antagonists (randomized controlled trials).
•In terms of clinical research :
- Study the impacted consequences of stroke by socio-economic characteristics of the territories in the Pays de Brest
- Identify short and long term clinical predictors of mortality in patients who have had a hemorrhagic stroke.
- To identify clinical predictors of mortality in the short and long-term patients with ischemic stroke.
- To identify genetic predictors of mortality and long-term recurrence of patients with ischemic stroke
- Identify stroke identification algorithm from existing databases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnostic validated for one of the following pathologies: * Ischemic stroke, * Non-traumatic intracranial hematoma * Cerebral venous thrombosis Diagnostic after December 31, 2007 Age > 15 years on the date of the diagnostic Patient domiciled at the time of the diagnostic in one of the 79 communes defined beforehand
Key inclusion criteria (4 listed)
- Diagnostic validated for one of the following pathologies:
- Ischemic stroke,
- Non-traumatic intracranial hematoma
- Cerebral venous thrombosis Diagnostic after December 31, 2007 Age > 15 years on the date of the diagnostic Patient domiciled at the time of the diagnostic in one of the 79 communes defined beforehand
Key exclusion criteria (5 listed)
- Age ≤ 15 years
- Validated diagnosis (see below, § 4.2.2) of aneurysmal subarachnoid hemorrhage cerebrovascular
- Diagnosis made before 1 January 2008
- Unconfirmed diagnosis
- Patient domiciled outside the previously defined area of residence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of stroke (ischemic or haemorrhagic)
Time frame: Inclusion
The type of stroke ischemic or haemorrhagic will be collected from physician diagnostic
1 secondary outcome
Patient outcome
Time frame: Every year after the inclusion during 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 26 May 2023.
- Individual participant dataSharing planned: Yes
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.
Serge TIMSIT principal investigator
CHRU La Cavale Blanche - BREST - FRANCE
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 Cerebral (CVAs) and Ischemic Cerebrovascular Accident, run by University Hospital, Brest 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 4 inclusion and 5 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 26 May 2023. 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 Serge TIMSIT (+33298347620, serge.timsit@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of stroke (ischemic or haemorrhagic) (time frame: Inclusion). 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 26 May 2023.