Population-based Brest Stroke Registry

Stroke Clinical Trial

— BREST  

Official title:

The Brest Registry of Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02900521
• Other study ID #: REGISTRE AVC
• Status: Recruiting
• Start date: January 2008
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: University Hospital, Brest
• Contact: Serge TIMSIT
• Phone: +33298347620
• Email: serge.timsit[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 2026
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Hemorrhage
• Brain Ischemia
• Cerebral (CVAs)
• Cerebrovascular Disorders
• Hemorrhage
• Hemorrhagic Stroke
• Intracranial Hemorrhages
• Ischemia
• Ischemic Attack, Transient
• Ischemic Cerebrovascular Accident
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack (TIA)

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Brest	Institut National de la Santé Et de la Recherche Médicale, France, Santé publique France-InVS (Institut National de Veille sanitaire)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of stroke (ischemic or haemorrhagic)	The type of stroke ischemic or haemorrhagic will be collected from physician diagnostic	Inclusion
Secondary	Patient outcome	Patient outcome (mortality) wanted by mail from towns of birth	Every year after the inclusion during 10 years