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Clinical Trials/NCT06995040
NCT06995040RecruitingNot Applicable

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

University Hospital, Brest1 site in 1 country1,000 target enrollmentStarted: June 18, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,000
Locations
1
Primary Endpoint
Quality of life score

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Minor ischemic stroke

Other

Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago

Intervention: Cerebral MRI without contrast agent injection (Diagnostic Test)

Minor ischemic stroke

Other

Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago

Intervention: saliva sample (Genetic)

Minor ischemic stroke

Other

Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago

Intervention: Questionnaires (Other)

Outcomes

Primary Outcomes

Quality of life score

Time Frame: At inclusion

Quality of life score is evaluated with the SF-36 questionnaire. It is a dichotomized score : good or bad recovery

Secondary Outcomes

  • Recurrence(At inclusion)
  • Mortality(At inclusion)
  • EQ5D score(At inclusion)
  • Stroke Impact Scale(At inclusion)
  • Rankin score(At inclusion)
  • Utility-Weighted Modified Rankin Scale(At inclusion)
  • WHO Disability Assessment Schedule (WHODAS)(At inclusion)
  • Clinical Functioning Information Tool (ClinFIT)(At inclusion)
  • Montreal Cognitive Assesment (MoCA)(At inclusion)
  • Mini Mental State Examination (MMSE)(At inclusion)
  • Center for Epidemiologic Studies-Depression (CES-D)(At inclusion)
  • Generalized Anxiety Disorder-7 (GAD-7)(At inclusion)
  • Primary Care PTSD Screen for DSM-5 (PTSD-5)(At inclusion)
  • APATHY INVENTORY IA(At inclusion)
  • Multidimensional Fatigue Inventory (MFI)(At inclusion)
  • Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)(At inclusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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