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

Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Ischemic Stroke
• Intervention / Treatment: Other: Immuno-inflammatory profile description in patients with ischemic stroke

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin MAIER, Professor, MD, PhD; Phone Number: + 33 01 48 03 65 56; Email: bmaier@for.paris
• Study Contact Backup: Name: Amélie YAVCHITZ, MD, PhD; Phone Number: + 33 01 48 03 64 54; Email: ayavchitz@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment	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 preconfigurated panels for inflammatory biomarkers.	Up to year

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): May 15, 2028

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: BMR_2020_31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No