Population-based Brest Stroke Registry (BREST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02900521|
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
|Condition or disease|
|Cerebral (CVAs) Ischemic Cerebrovascular Accident Stroke Brain Ischemia Brain Hemorrhage Ischemic Stroke Hemorrhagic Stroke Cerebrovascular Disorders Transient Ischaemic Attack (TIA),|
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.
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||900 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||The Brest Registry of Stroke|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||December 2026|
- Type of stroke (ischemic or haemorrhagic) [ Time Frame: Inclusion ]The type of stroke ischemic or haemorrhagic will be collected from physician diagnostic
- Patient outcome [ Time Frame: Every year after the inclusion during 10 years ]Patient outcome (mortality) wanted by mail from towns of birth
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900521
|Contact: Serge TIMSITfirstname.lastname@example.org|
|CHRU de Brest||Recruiting|
|Brest, France, 29200|
|Contact: Serge TIMSIT +33298347620 email@example.com|
|Sub-Investigator: Francois ROUHART|
|Sub-Investigator: Irina VIAKHIREVA|
|Sub-Investigator: François Mathias MERRIEN|
|Sub-Investigator: Philippe GOAS|
|Principal Investigator:||Serge TIMSIT||CHRU La Cavale Blanche - BREST - FRANCE|