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

NCT ID: NCT04701619

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-15
• Study Completion Date: 2028-05-15

Brief Summary

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.

Conditions

Stroke; Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Immuno-inflammatory profile description in patients with ischemic stroke

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

Group Type: OTHER

Immuno-inflammatory profile description in patients with ischemic stroke

Intervention Type: OTHER

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

Interventions

Immuno-inflammatory profile description in patients with ischemic stroke

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Benjamin MAIER, Professor, MD, PhD

Role: CONTACT

bmaier@for.paris

01 48 03 65 56 ext. + 33

Amélie YAVCHITZ, MD, PhD

Role: CONTACT

ayavchitz@for.paris

01 48 03 64 54 ext. + 33

Other Identifiers

BMR_2020_31

Identifier Type: -

Identifier Source: org_study_id