BREMISS : Brain Resilience Minor Stroke Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cerebral MRI without contrast agent injection, saliva sample, Questionnaires.
- Who it may be relevant to
- Registry conditions: Stroke Ischemic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Initial Predictors of Long-term Brain Resilience After Minor Ischemic Stroke: a Study Nested in the Brest Stroke Population-based Registry
Overview
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.
Interventions
- 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
Primary outcome measures
- Quality of life score [Time frame: At inclusion]
Secondary outcome measures (12)
- EQ5D score [Time frame: At inclusion]
- Stroke Impact Scale [Time frame: At inclusion]
- Mortality [Time frame: At inclusion]
- Recurrence [Time frame: At inclusion]
- Rankin score [Time frame: At inclusion]
- Utility-Weighted Modified Rankin Scale [Time frame: At inclusion]
- WHO Disability Assessment Schedule (WHODAS) [Time frame: At inclusion]
- Clinical Functioning Information Tool (ClinFIT) [Time frame: At inclusion]
- Montreal Cognitive Assesment (MoCA) [Time frame: At inclusion]
- Mini Mental State Examination (MMSE) [Time frame: At inclusion]
- Center for Epidemiologic Studies-Depression (CES-D) [Time frame: At inclusion]
- Generalized Anxiety Disorder-7 (GAD-7) [Time frame: At inclusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU de Brest — Brest
Identifiers
NCT: NCT06995040 · 29BRC23.0188 - BREMISS