Clinical trial NCT06995040: BREMISS : Brain Resilience Minor Stroke Study
Official title: Initial Predictors of Long-term Brain Resilience After Minor Ischemic Stroke: a Study Nested in the Brest Stroke Population-based Registry
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Ischemic
Keywords: stroke
Predictive model
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Quality of life score
timeFrame: At inclusion
Secondary outcomes:
measure: EQ5D score
timeFrame: At inclusion
measure: Stroke Impact Scale
timeFrame: At inclusion
measure: Mortality
timeFrame: At inclusion
measure: Recurrence
timeFrame: At inclusion
measure: Rankin score
timeFrame: At inclusion
measure: Utility-Weighted Modified Rankin Scale
timeFrame: At inclusion
measure: WHO Disability Assessment Schedule (WHODAS)
timeFrame: At inclusion
measure: Clinical Functioning Information Tool (ClinFIT)
timeFrame: At inclusion
measure: Montreal Cognitive Assesment (MoCA)
timeFrame: At inclusion
measure: Mini Mental State Examination (MMSE)
timeFrame: At inclusion
measure: Center for Epidemiologic Studies-Depression (CES-D)
timeFrame: At inclusion
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: At inclusion
measure: Primary Care PTSD Screen for DSM-5 (PTSD-5)
timeFrame: At inclusion
measure: APATHY INVENTORY IA
timeFrame: At inclusion
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: At inclusion
measure: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
timeFrame: At inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
affiliation: CHU de Brest
name: Serge TIMSIT, Pr
role: PRINCIPAL_INVESTIGATOR
References: