Identification of Biomarkers in Ischemic Stroke - Clinical Trial

Last updated: March 1, 2024
Sponsor: University Hospital, Brest
Overall Status: Completed

Phase

N/A

Condition

Stroke

Occlusions

Cardiac Ischemia

Treatment

blood samples

MRI without injection

Clinical Study ID

NCT04253275
IBIS-CT (29BRC19.0268)
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of the study is to determine RNA blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For ischemic stroke :
  • Age > 18-year-old
  • Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRIimaging)
  • Inclusion inferior to 6 hours from stroke onset
  • Initial NIHSS score > 0 at the time of clinical examination
  • Patients with multimodal imaging either through MRI or CT perfusion and supra-aorticvessels and intra-cerebral vessels (Willis circle) imaging <0
  • Procedure of signed consent in situation of emergency : consent of the patient if hehas the possibility to sign or his representative if he is present
  • For hemorragic stroke :
  • Age > 18 year-old
  • Hemorrhagic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRIimaging)
  • Inclusion inferior to 6 hours from stroke onset
  • Initial NIHSS score > 0 at the time of clinical examination
  • Hemorrhagic patients are paired for age and sex with ischemic patients
  • Procedure of signed consent in situation of emergency : consent of the patient if hehas the possibility to sign or his representative if he is present For healthy controls :
  • Age > 18 year-old
  • Stroke-free standardized questionnaire
  • Initial NIHSS score = 0
  • Rankin score = 0
  • High risk cardiovascular subjects
  • Controls are paired for age, sex and cardiovascular risk measured by a score (EuropeanHeart Score) with ischemic patients

Exclusion

Exclusion Criteria:

  • Not affiliated to social security

  • Patient under legal protection or deprived of liberty by a judicial or administrativedecision

  • Patient whose follow-up will be impossible

  • Prior stroke GROUP FOR ISCHEMIC STROKE :

  • Patients with TIA and a negative cerebral CT or MRI GROUP FOR HEMORRAGIC STROKE :

  • Cerebral hemorrhage related to subarachnoid hemorrhage

  • Post-traumatic hemorrhage

  • Hemorrhagic transformation in patients with ischemic stroke GROUP FOR HEALTHY CONTROLS :

  • Contraindication MRI

Study Design

Total Participants: 61
Treatment Group(s): 2
Primary Treatment: blood samples
Phase:
Study Start date:
November 24, 2020
Estimated Completion Date:
February 06, 2024

Study Description

This is a monocentric study. It's a case-control study with case being first-ever ischemic stroke and controls being healthy (stroke free) subject patients paired for age, sex and cardiovascular risk or hemorrhagic stroke paired for age and sex.

Patients are followed for one year. Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y. Microvesicles samples will be taken at inclusion, 7d and 3M.

Connect with a study center

  • CHRU Brest

    Brest,
    France

    Site Not Available

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