Population-based Brest Stroke Registry (BREST)

May 25, 2023 updated by: University Hospital, Brest

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Brest, France, 29200
        • Recruiting
        • CHRU de Brest
        • Contact:
        • Sub-Investigator:
          • Francois ROUHART
        • Sub-Investigator:
          • Irina VIAKHIREVA
        • Sub-Investigator:
          • François Mathias MERRIEN
        • Sub-Investigator:
          • Philippe GOAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of stroke (ischemic or haemorrhagic)
Time Frame: Inclusion
The type of stroke ischemic or haemorrhagic will be collected from physician diagnostic
Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient outcome
Time Frame: Every year after the inclusion during 10 years
Patient outcome (mortality) wanted by mail from towns of birth
Every year after the inclusion during 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Santé publique France-InVS (Institut National de Veille sanitaire)

Investigators

  • Principal Investigator: Serge TIMSIT, CHRU La Cavale Blanche - BREST - FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

August 1, 2016

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimated)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGISTRE AVC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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