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NCT Number: NCT02900521

Population-based Brest Stroke Registry

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

Recruiting

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29200, France

Location status: Recruiting

Location contact

Francois ROUHART

SUB_INVESTIGATOR

François Mathias MERRIEN

SUB_INVESTIGATOR

Irina VIAKHIREVA

SUB_INVESTIGATOR

Philippe GOAS

SUB_INVESTIGATOR

Serge TIMSIT

CONTACT

[email protected]

+33298347620

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Type of stroke (ischemic or haemorrhagic)

    Time frame: Inclusion

    The type of stroke ischemic or haemorrhagic will be collected from physician diagnostic

Secondary outcomes

  1. Patient outcome

    Time frame: Every year after the inclusion during 10 years

    Patient outcome (mortality) wanted by mail from towns of birth

Study contacts

Contact information is provided by the study sponsor or research team.

Serge TIMSIT

CONTACT

[email protected]

+33298347620

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

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

Registry information

Official study title

The Brest Registry of Stroke

Acronym: BREST

Important dates

Study start
2008
Primary completion
2016
Study completion
2026
First posted
Sep 14, 2016
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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