BREST: Population-based Brest Stroke Registry

Sponsor

University Hospital, Brest (Other)

Overall Status

Recruiting

CT.gov ID

NCT02900521

Collaborator

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

900

Enrollment

Location

227

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

900 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Brest Registry of Stroke

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Dec 1, 2026

Outcome Measures

Primary Outcome Measures

Type of stroke (ischemic or haemorrhagic) [Inclusion]
The type of stroke ischemic or haemorrhagic will be collected from physician diagnostic

Secondary Outcome Measures

Patient outcome [Every year after the inclusion during 10 years]
Patient outcome (mortality) wanted by mail from towns of birth

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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