Identification of Biomarkers in Ischemic Stroke - Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Identification of Biomarkers in Ischemic Stroke - Clinical Trial

Conditions
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Stroke, Ischemic, Stroke Hemorrhagic

Intervention / Treatment
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* Genetic: blood samples
* Diagnostic Test: MRI without injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ischemic stroke patients<br>Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging | Genetic: blood samples<br>* 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.<br>|
| Other: hemorragic stroke patients<br>Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging | Genetic: blood samples<br>* 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.<br>|
| Other: healthy controls<br>Stroke-free | Genetic: blood samples<br>* 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.<br>Diagnostic Test: MRI without injection<br>* MRI at inclusion for controls<br>|

What is the study measuring?
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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 |