Initial Predictors of Long-term Brain Resilience After Minor Ischemic Stroke: a Study Nested in the Brest Stroke Population-based Registry
| Registry | NCT06995040, acronym BREMISS |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 1000 (Estimated) |
| Sponsor | University Hospital, Brest (Other) |
| Conditions | Stroke Ischemic |
| Interventions | Cerebral MRI without contrast agent injection, saliva sample, Questionnaires (Diagnostic test, genetic, other) |
| Dates | start 2025-06-18, primary completion 2027-12-18 (estimated), completion 2028-12-18 (estimated), first posted 2025-05-29, last updated 2026-02-23 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Stroke Ischemic All trials of Cerebral MRI without contrast agent injection All trials of saliva sample
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)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Minor ischemic stroke | Other | Diagnostic Test: Cerebral MRI without contrast agent injection; Genetic: saliva sample; Other: Questionnaires | Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| CHU de Brest | Brest | France | Recruiting |