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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Stroke Hemorrhagic; Stroke, Ischemic

Treatments: Genetic: blood samples; Diagnostic Test: MRI without injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04253275

IBIS-CT (29BRC19.0268)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 3 patient groups

Ischemic stroke patients

Other group

Description:

Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging

Treatment:

Genetic: blood samples

hemorragic stroke patients

Other group

Description:

Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging

Treatment:

Genetic: blood samples

healthy controls

Other group

Description:

Stroke-free

Treatment:

Diagnostic Test: MRI without injection

Genetic: blood samples