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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic; Stroke Hemorrhagic
• Intervention / Treatment: Genetic: blood samples; Diagnostic test: MRI without injection

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France
    • CHRU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 hours after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	inclusion and 3 months
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	at 3 months
Targeted RNA level expression according mechanism of ischemic stroke	Each targeted RNA level expression of targeted genes will be measured by quantitative rt-PCR	at 3 months
Target RNA level expression in the saliva	For 3 participants, one of each arm, a saliva sample will be collected at inclusion.	at inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Serge TIMSIT, Pr, serge.timsit@chu-brest.fr

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): February 6, 2024

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia; Hemorrhagic Stroke
• Other Study ID Numbers: IBIS-CT (29BRC19.0268)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No