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

NCT04701619 | Not Yet Recruiting

• 1 other identifier: BMR_2020_31
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Immuno-inflammatory profile description in patients with ischemic stroke

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

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

Interventions

Immuno-inflammatory profile description in patients with ischemic stroke 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

Immuno-inflammatory profile description in patients with ischemic stroke

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Affiliated with or beneficiary of a social security system

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Benjamin MAIER, Professor, MD, PhD

CONTACT

01 48 03 65 56; bmaier@for.paris

Amélie YAVCHITZ, MD, PhD

CONTACT

01 48 03 64 54; ayavchitz@for.paris

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: All patients undergoing a reperfusion procedure as part of an ischemia stroke will be able to participate in the study.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: January 8, 2021
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01