Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies (IMMUNOSTROKE)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Begins enrollment in 7 months

Conditions: Ischemic Stroke; Stroke

Treatments: Other: Immuno-inflammatory profile description in patients with ischemic stroke

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04701619

BMR_2020_31

Details and patient eligibility

About

IMMUNOSTROKE study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of AIC management by reperfusion treatment and to monitor changes in these different parameters over time. Post-hoc analyses will make it possible to correlate the immuno-inflammatory and thrombo-inflammatory profiles and their evolution with the clinical outcome in terms of post-AIC functional and cognitive disability.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient over 18 years of age
• Presenting with an ACS for which reperfusion therapy is indicated according to European and North American recommendations (IV thrombolysis or mechanical thrombectomy or a combination of both)
• Having received informed information about the study and having signed a consent form to participate in the study (if this is not possible: information and consent from a trusted person or family member if present; emergency inclusion if absent)
• Affiliated with or beneficiary of a social security system

Exclusion criteria

• Contraindication to performing a brain MRI (claustrophobia, pacemaker, or other implantable device contraindicating the performance of an MRI)
• Intracranial hemorrhage associated with AIC on initial imaging

Immunosuppressive treatment or corticosteroid therapy at patient admission

• Pre-existing neurological disability limiting neurological assessment at 3 months (mRS>2 at admission)
• Known and diagnosed dementia pre-existing at the time of the AIC
• Absolute or relative contraindication to the injection of gadolinium (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance <15mL/min, pregnant or breastfeeding women)
• Patient treated by another institution and referred solely for mechanical thrombectomy
• Patient benefiting from legal protection measures

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Immuno-inflammatory profile description in patients with ischemic stroke

Other group

Description:

Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA panels for inflammatory biomarkers

Treatment:

Other: Immuno-inflammatory profile description in patients with ischemic stroke