Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke, Ischemic
- Sponsor
- University Hospital, Brest
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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)
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
Outcomes
Primary Outcomes
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
- Target RNA level expression in the saliva(at inclusion)
- Targeted RNA level expression according mechanism of ischemic stroke(at 3 months)
- RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).(at 3 months)
- RNA level expression across time according growth of infarction measured at inclusion and at 3 months(inclusion and 3 months)