BREMISS : Brain Resilience Minor Stroke Study

NCT06995040 | Recruiting

• 1 other identifier: 29BRC23.0188 - BREMISS
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to develop, based on patients' initial characteristics (in the first few weeks following the stroke), a predictive model of quality of life more than 4 years after the stroke in patients who have suffered a minor ischemic stroke. The main question it aims to answer is: \- Is it possible to predict the quality of life of patients who have suffered a minor ischemic stroke based on their initial characteristics? To do this, retrospective and prospective data collected as part of the study will be analyzed using a conventional statistical approach and algorithms based on AI approaches in order to create a predictive model. Participants will be asked to:

• Complete questionnaires
• Provide a saliva sample (optional)
• Undergo an MRI scan (optional)

Conditions

Stroke Ischemic

Keywords

stroke; Predictive model

Outcome Measures

Primary Outcomes (1)

• Quality of life score

  Quality of life score is evaluated with the SF-36 questionnaire. It is a dichotomized score : good or bad recovery

  At inclusion

Secondary Outcomes (16)

• EQ5D score

  At inclusion

• Stroke Impact Scale

  At inclusion

• Mortality

  At inclusion

• Recurrence

  At inclusion

• Rankin score

  At inclusion

Study Arms (1)

Minor ischemic stroke

OTHER

Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago

Diagnostic Test: Cerebral MRI without contrast agent injection; Genetic: saliva sample; Other: Questionnaires

Interventions

Cerebral MRI without contrast agent injection DIAGNOSTIC_TEST

Cerebral MRI at inclusion or after

Minor ischemic stroke

saliva sample GENETIC

Saliva sample for DNA analysis at inclusion or send to their home.

Minor ischemic stroke

Questionnaires OTHER

Quality of life and cognitive questionnaires at inclusion

Minor ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases of stroke in the Brest Stroke Registry (BSR)
• Ability to sign informed consent
• Patients followed-up \> 4 years during the study period
• NIHSS score ≤ 5 on admission
• First stroke above 18 and before 75-year old
• Rankin before stroke \< 1
• Possibility to draw saliva samples for genomic study
• Possibility to perform Cerebral MRI

You may not qualify if:

• Patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded.
• Not affiliated to social security
• Patient under legal protection or deprived of liberty by a judicial or administrative decision
• Patient unable to sign informed consent
• Patient whose follow-up will be impossible

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Serge TIMSIT, Pr

  CHU de Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serge TIMSIT, Pr

CONTACT

298147349; serge.timsit@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Retrospective cohort data for baseline characteristics and prospective data for more than 4 years information. Methodology that will be developed will include both classical statistical analysis and algorithm development based on AI approaches. * For classical statistical approach principal analysis will be analyzed with a logistic regression model allowing multivariate analysis. * AI models will be trained in Python using libraries Pytorch and Scikit-learn. We will consider a wide set of regression models to compare their performance on validation cohorts. The list includes (but is not limited to) KNNs (K-Nearest Neighbors), SVMs (Support vector machine) and deep learning models.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 29, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 18, 2027
• Study Completion (Estimated): December 18, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)