Skip to main content
OpenTrials
Completed

NCT Number: NCT04253275

Identification of Biomarkers in Ischemic Stroke - Clinical Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Stroke Stroke Hemorrhagic Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Brest

Brest, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For ischemic stroke :
  • Age > 18-year-old
  • Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
  • 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-aortic vessels and intra-cerebral vessels (Willis circle) imaging <0
  • Procedure of signed consent in situation of emergency : consent of the patient if he has 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 MRI imaging)
  • 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 he has 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 (European Heart Score) with ischemic patients

Exclusion criteria

  • Not affiliated to social security
  • Patient under legal protection or deprived of liberty by a judicial or administrative decision
  • 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

Treatment and study plan

blood samples

Genetic

Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y for patients ; at inclusion, 3m and 1y for controls.

Microvesicles samples will be taken at inclusion, 7d and 3M ; at inclusion and 3M for controls.

MRI without injection

Diagnostic Test

MRI at inclusion for controls

Primary outcomes

  1. Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion

    Time frame: 6 hours after inclusion

    Each targeted genes will be measured by quantitative reverse transcription Polymerase Chain Reaction (rt-PCR)

Secondary outcomes

  1. RNA level expression across time according growth of infarction measured at inclusion and at 3 months

    Time frame: inclusion and 3 months

    Each targeted genes will be measured by quantitative rt-PCR

  2. RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).

    Time frame: at 3 months

    Each targeted genes will be measured by quantitative rt-PCR

  3. Targeted RNA level expression according mechanism of ischemic stroke

    Time frame: at 3 months

    Each targeted RNA level expression of targeted genes will be measured by quantitative rt-PCR

  4. Target RNA level expression in the saliva

    Time frame: at inclusion

    For 3 participants, one of each arm, a saliva sample will be collected at inclusion.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: IBIS-CT

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2020
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.