NCT06995040

BREMISS : Brain Resilience Minor Stroke Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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.

Conditions

• Stroke Ischemic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-18
• Primary completion: 2027-12-18
• Completion: 2028-12-18
• First posted: 2025-05-29
• Last updated: 2026-02-23

Locations

1 site across 1 country: France