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Identification of Biomarkers in Ischemic Stroke - Clinical Trial (IBIS-CT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253275
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Stroke Hemorrhagic Genetic: blood samples Diagnostic Test: MRI without injection Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ischemic stroke patients
Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging
Genetic: blood samples

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.


hemorragic stroke patients
Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging
Genetic: blood samples

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.


healthy controls
Stroke-free
Genetic: blood samples

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.


Diagnostic Test: MRI without injection
MRI at inclusion for controls




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253275


Contacts
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Contact: Serge TIMSIT, Pr 298147349 ext +33 serge.timsit@chu-brest.fr

Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Serge TIMSIT, Pr serge.timsit@chu-brest.fr
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04253275    
Other Study ID Numbers: IBIS-CT (29BRC19.0268)
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes