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BREMISS : Brain Resilience Minor Stroke Study

R

Regional University Hospital Center (CHRU)

Status

Not yet enrolling

Conditions

Stroke Ischemic

Treatments

Diagnostic Test: Cerebral MRI without contrast agent injection
Genetic: saliva sample
Other: Questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT06995040
29BRC23.0188 - BREMISS

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,000 participants in 1 patient group

Minor ischemic stroke
Other group
Description:
Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago
Treatment:
Other: Questionnaires
Genetic: saliva sample
Diagnostic Test: Cerebral MRI without contrast agent injection

Trial contacts and locations

1

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Central trial contact

Serge TIMSIT, Pr

Data sourced from clinicaltrials.gov

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