BREMISS : Brain Resilience Minor Stroke Study (BREMISS)

Initial Predictors of Long-term Brain Resilience After Minor Ischemic Stroke: a Study Nested in the Brest Stroke Population-based Registry

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)

Study Overview

• Status: Recruiting
• Conditions: Stroke Ischemic
• Intervention / Treatment: Diagnostic test: Cerebral MRI without contrast agent injection; Genetic: saliva sample; Other: Questionnaires

Detailed Description

Brain resilience: The human brain shows remarkable inter-individual differences in coping with pathological insults. This is observed in particular after ischemic stroke with patients with similar types of stroke showing very different functional outcomes ranging from complete recovery to severe disability.

Minor stroke: In population-based studies, approximately two-thirds of ischemic stroke patients have mild deficits. Minor stroke is generally defined as a National Institute of Health Stroke Scale (NIHSS) of 5 or less. The term minor stroke takes into account certain deficits but not the fact that some can have a more profound impact on quality of life than others. Minor strokes have a 30-day fatality rate very low but approximately 30% of patients with minor strokes have poor functional outcomes at 90-days. In patients with minor stroke impairment of health-related quality of life is however present in 35.8% of case at 3-months.Long term outcome (> 90-days) is less well known. An analysis of the population-based Oxford Vascular Study showed that, in minor stroke with an NIHSS < 3, the incidence of post-event dementia at 1 year was 8.2% (6.2-10.2). The 5-year risk of dementia was found associated with age, event severity, previous stroke, dysphasia, baseline cognition, low education, pre-morbid dependency, leucoaraiosis, and diabetes. Cognitive sequelae of minor strokes are frequent involving overall executive functions, attention, working memory, processing speed, visual & verbal memory, verbal fluency and other. There is a need for big data, big imaging: many studies have less than 100 patients, none had 1000 patients

The principal objective is to develop, from initial (first weeks after stroke onset) patients' characteristics, a predictive model of quality of life more than 4 years after stroke onset in patients with minor ischemic stroke.

Patients included in the Brest Stroke Registry (all cases of stroke in patients aged above 15 years occurring in a defined area known as the "Pays de Brest", in Brittany, western France) who meet the inclusion and non-inclusion criteria will be proposed to participate to the study to have either a telephone interview or a face-to-face interview with a neurologist and a clinical research technician more than 4 years from stroke hospitalization.

In the case of telephone interview they will be proposed to have a saliva sample for DNA analysis send to their home that will need to be send back to the hospital.

In the case of face-to-face interview, patient will be proposed to have on the spot a saliva sample for DNA and a cerebral MRI.

Chaining patients from the BRE and hospital medical record: Pairing between databases-i.e BRE and hospital medical electronic record will be established.

Retrospective cohort data for baseline characteristics and prospective data for more than 4 years information.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serge TIMSIT, Pr; Phone Number: +33 298147349; Email: serge.timsit@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • Chu de Brest
    • Contact: Serge TIMSIT, Pr; Phone Number: +33 298147349; Email: serge.timsit@chu-brest.fr
    • Principal Investigator: Serge TIMSIT, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Minor ischemic stroke; 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; Cerebral MRI at inclusion or after; Genetic: saliva sample; Saliva sample for DNA analysis at inclusion or send to their home.; Other: Questionnaires; Quality of life and cognitive questionnaires at inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D score	It is a questionnaire to describe patient's health with 5 items (Mobility; Autonomy; Activity; Pain/Discomfort; Anxiety/Depression) with 5 anwers each (No problem/light problems/moderate problem/serious problems/incapable)	At inclusion
Stroke Impact Scale	Stroke Impact Scale includes 59 items and assesses 8 domains: Strength (4 items), Hand function (5 items), ADL/IADL (10 items), Mobility (9 items), Communication (7 items), Emotion (9 items), Memory and thinking (7 items), Participation/Role function (8 items)	At inclusion
Mortality	Mortality is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago.	At inclusion
Recurrence	Recurrence is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago.	At inclusion
Rankin score	It is a scale about disability after stroke. The score is between 0 (no symptom) to 5 (serious disability). The study uses Rankin score dichotomized in good [0-1] and bad [2-5] prognosis.	At inclusion
Utility-Weighted Modified Rankin Scale	The Modified Rankin Scale is a measure of functional outcome after stroke, evaluating the degree of disability or dependence in daily life. There is 7 grades ranging from 0 (no symptoms) to 6 (death).	At inclusion
WHO Disability Assessment Schedule (WHODAS)	It is an auto-questionnaire of disability in daily life. There are 15 questions with 5 anwers ranging from 0 (No disability) to 5 (extreme disability/incapability)	At inclusion
Clinical Functioning Information Tool (ClinFIT)	It is an auto-questionnaire to evaluate patient functioning. There are 30 questions, with score ranging from 0 (no problem) to 30 (complete problem).	At inclusion
Montreal Cognitive Assesment (MoCA)	It is a cognition test with 7 items (visuospatial; designation; memory; attention; langage; abstraction; orientation). The total score is ranging from 0 to 30 points.	At inclusion
Mini Mental State Examination (MMSE)	It is a cognition test with 6 items (orientation ; learning ; attention/calculation ; reminder; langage ; visuospatial constructive). The total score is ranging from 0 to 30 points.	At inclusion
Center for Epidemiologic Studies-Depression (CES-D)	It is an auto-questionnaire to evaluate depression with 20 questions. There are 6 answers with score ranging from 0 to 6 (0 : Never/very rarely ; 1: rarely; 2 :quite often; 3: frequently/always).	At inclusion
Generalized Anxiety Disorder-7 (GAD-7)	It is an auto-questionnaire for screening of generalized anxiety disorder with 7 questions. There are 4 answers : Never / Several days / More than half the days / Almost every day.	At inclusion
Primary Care PTSD Screen for DSM-5 (PTSD-5)	It is an auto-questionnaire to evaluate stroke experience. there are 5 questions with 2 answers Yes/No	At inclusion
APATHY INVENTORY IA	It is an auto-questionnaire to obtain information on the presence of apathy in patients with brain disorders. There are 3 items : emotional blunting; loss of initiative; loss of interest, with score ranging from 0 (mild) to 12 (severe).	At inclusion
Multidimensional Fatigue Inventory (MFI)	It is an auto-questionnaire to evaluate fatigue. There are 10 items with score ranging from 1 (not agree at all) to 5 (completely agree)	At inclusion
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)	It is a questionnaire to evaluate cognitive declin, with 16 questions, with score ranging from 1 (much better) to 5 (much worse)	At inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Serge TIMSIT, Pr, Chu de Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Estimated): December 18, 2027
• Study Completion (Estimated): December 18, 2028

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: May 21, 2025
• First Posted (Actual): May 29, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stroke; Predictive model
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 29BRC23.0188 - BREMISS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No