BREMISS : Brain Resilience Minor Stroke Study
- Conditions
- Stroke Ischemic
- Registration Number
- NCT06995040
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
All patients eligible recorded in the Brest Stroke Registry (BSR) will be proposed to have either a telephone interview or a face-to-face interview.
In the case of telephone interview, they will be proposed to have a saliva kit for DNA analysis send to their home at the time as the self-questionnaires that will need to be send back to the hospital.
In the case of face-to-face interview, they will be proposed to have on the spot a saliva sample for DNA and a cerebral MRI.
Around 1000 patients can be included.
- Detailed Description
The study is a retrospective study for pairing the population-based stroke registry and hospital medical record data and prospective study for calling back patient more than 4 years for new clinical, cognitive, thymic and quality of life evaluations and for DNA sample and cerebral MRI realization Duration of recruitment is anticipated to last between 2 years and 2 years and half.
The principal objective is to develop a predictive model of quality of life more than 4 years after stroke onset in patients with minor stroke based on initial (first days after stroke onset) patients characteristics based on the assumption that more than 4 years after a stroke the related sequelae are going to be stable.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Quality of life score At inclusion Quality of life score is evaluated with the SF-36 questionnaire. It is a dichotomized score : good or bad recovery
- Secondary Outcome Measures
Name Time Method Center for Epidemiologic Studies-Depression (CES-D) At inclusion 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).
Generalized Anxiety Disorder-7 (GAD-7) At inclusion 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.
Primary Care PTSD Screen for DSM-5 (PTSD-5) At inclusion It is an auto-questionnaire to evaluate stroke experience. there are 5 questions with 2 answers Yes/No
APATHY INVENTORY IA At inclusion 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).
Multidimensional Fatigue Inventory (MFI) At inclusion 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)
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) At inclusion It is a questionnaire to evaluate cognitive declin, with 16 questions, with score ranging from 1 (much better) to 5 (much worse)
Clinical Functioning Information Tool (ClinFIT) At inclusion It is an auto-questionnaire to evaluate patient functioning. There are 30 questions, with score ranging from 0 (no problem) to 30 (complete problem).
Montreal Cognitive Assesment (MoCA) At inclusion 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.
Mini Mental State Examination (MMSE) At inclusion 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.
EQ5D score At inclusion 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)
Stroke Impact Scale At inclusion 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)
Mortality At inclusion Mortality is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago.
Recurrence At inclusion Recurrence is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago.
Rankin score At inclusion 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.
Utility-Weighted Modified Rankin Scale At inclusion 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).
WHO Disability Assessment Schedule (WHODAS) At inclusion 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)
Trial Locations
- Locations (1)
CHU de Brest
🇫🇷Brest, France
CHU de Brest🇫🇷Brest, FranceSerge TIMSIT, PrPrincipal Investigator