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

Primary Purpose

Stroke, Ischemic, Stroke Hemorrhagic

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
MRI without injection
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHRU BrestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Ischemic stroke patients

hemorragic stroke patients

healthy controls

Arm Description

Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging

Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging

Stroke-free

Outcomes

Primary Outcome Measures

Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion
Each targeted genes will be measured by quantitative reverse transcription Polymerase Chain Reaction (rt-PCR)

Secondary Outcome Measures

RNA level expression across time according growth of infarction measured at inclusion and at 3 months
Each targeted genes will be measured by quantitative rt-PCR
RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).
Each targeted genes will be measured by quantitative rt-PCR
Targeted RNA level expression according mechanism of ischemic stroke
Each targeted RNA level expression of targeted genes will be measured by quantitative rt-PCR
Target RNA level expression in the saliva
For 3 participants, one of each arm, a saliva sample will be collected at inclusion.

Full Information

First Posted
January 7, 2020
Last Updated
May 10, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04253275
Brief Title
Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Acronym
IBIS-CT
Official Title
Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke Hemorrhagic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ischemic stroke patients
Arm Type
Other
Arm Description
Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging
Arm Title
hemorragic stroke patients
Arm Type
Other
Arm Description
Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging
Arm Title
healthy controls
Arm Type
Other
Arm Description
Stroke-free
Intervention Type
Genetic
Intervention Name(s)
blood samples
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI without injection
Intervention Description
MRI at inclusion for controls
Primary Outcome Measure Information:
Title
Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion
Description
Each targeted genes will be measured by quantitative reverse transcription Polymerase Chain Reaction (rt-PCR)
Time Frame
6 hours after inclusion
Secondary Outcome Measure Information:
Title
RNA level expression across time according growth of infarction measured at inclusion and at 3 months
Description
Each targeted genes will be measured by quantitative rt-PCR
Time Frame
inclusion and 3 months
Title
RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).
Description
Each targeted genes will be measured by quantitative rt-PCR
Time Frame
at 3 months
Title
Targeted RNA level expression according mechanism of ischemic stroke
Description
Each targeted RNA level expression of targeted genes will be measured by quantitative rt-PCR
Time Frame
at 3 months
Title
Target RNA level expression in the saliva
Description
For 3 participants, one of each arm, a saliva sample will be collected at inclusion.
Time Frame
at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serge TIMSIT, Pr
Phone
298147349
Ext
+33
Email
serge.timsit@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge TIMSIT, Pr
Organizational Affiliation
serge.timsit@chu-brest.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge TIMSIT, PU-PH
Email
serge.timsit@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Serge TIMSIT, PU-PH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing 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.

Learn more about this trial

Identification of Biomarkers in Ischemic Stroke - Clinical Trial

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