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Population-based Brest Stroke Registry (BREST)

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ClinicalTrials.gov Identifier: NCT02900521
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Collaborators:
Santé publique France-InVS (Institut National de Veille sanitaire)
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
The registry is the main objective exhaustive list of cases validated stroke brain on a geographical area defined to calculate an incidence.

Condition or disease
Cerebral (CVAs) Ischemic Cerebrovascular Accident Stroke Brain Ischemia Brain Hemorrhage Ischemic Stroke Hemorrhagic Stroke Cerebrovascular Disorders Transient Ischaemic Attack (TIA),

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:

  1. To obtain incidence data and evaluate the regional and international divergences
  2. 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.
  3. 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 :

  1. Study the impacted consequences of stroke by socio-economic characteristics of the territories in the Pays de Brest
  2. Identify short and long term clinical predictors of mortality in patients who have had a hemorrhagic stroke.
  3. To identify clinical predictors of mortality in the short and long-term patients with ischemic stroke.
  4. To identify genetic predictors of mortality and long-term recurrence of patients with ischemic stroke
  5. Identify stroke identification algorithm from existing databases

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. Type of stroke (ischemic or haemorrhagic) [ Time Frame: Inclusion ]
    The type of stroke ischemic or haemorrhagic will be collected from physician diagnostic


Secondary Outcome Measures :
  1. Patient outcome [ Time Frame: Every year after the inclusion during 10 years ]
    Patient outcome (mortality) wanted by mail from towns of birth



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Serge TIMSIT +3329847620 serge.timsit@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France, 29200
Contact: Serge TIMSIT    +33298347620    serge.timsit@chu-brest.fr   
Sub-Investigator: Francois ROUHART         
Sub-Investigator: Irina VIAKHIREVA         
Sub-Investigator: François Mathias MERRIEN         
Sub-Investigator: Philippe GOAS         
Sponsors and Collaborators
University Hospital, Brest
Santé publique France-InVS (Institut National de Veille sanitaire)
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Serge TIMSIT CHRU La Cavale Blanche - BREST - FRANCE

Additional Information:

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02900521     History of Changes
Other Study ID Numbers: REGISTRE AVC
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Ischemia
Intracranial Hemorrhages
Ischemia
Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes