Identification of Biomarkers in Ischemic Stroke - Clinical Trial

Not Applicable

Completed

• Conditions: Stroke, Ischemic; Stroke Hemorrhagic
• Interventions: Genetic: blood samples; Diagnostic Test: MRI without injection

• Registration Number: NCT04253275
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-11-24
• Status Verified: 2024-02
• Primary Completion: 2024-02-06
• Study Completion: 2024-02-06
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy controls	blood samples	Stroke-free
Ischemic stroke patients	blood samples	Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging
healthy controls	MRI without injection	Stroke-free
hemorragic stroke patients	blood samples	Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Target RNA level expression in the saliva	at inclusion	For 3 participants, one of each arm, a saliva sample will be collected at inclusion.
Targeted RNA level expression according mechanism of ischemic stroke	at 3 months	Each targeted RNA level expression of 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).	at 3 months	Each targeted genes will be measured by quantitative rt-PCR
RNA level expression across time according growth of infarction measured at inclusion and at 3 months	inclusion and 3 months	Each targeted genes will be measured by quantitative rt-PCR

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France