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

Not Applicable

Not yet recruiting

• Conditions: Ischemic Stroke; Stroke
• Interventions: Other: Immuno-inflammatory profile description in patients with ischemic stroke

• Registration Number: NCT04701619
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Study Start: 2024-09-15
• Primary Completion: 2025-10-15
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Presenting an ISCHEMIC STROKE for which reperfusion treatment is indicated according to European and North American recommendations (intraveinous thrombolysis or mechanical thrombectomy or a combination of both)

Exclusion Criteria

• Contraindication to performing a cerebral MRI (claustrophobia, pacemaker or other implantable device contraindicating the performance of MRI)
• Intracranial haemorrhage associated with AIC on initial imaging
• Immunosuppressive treatment or corticosteroid therapy on admission of the patient
• Pre-existing neurological disability limiting the neurological assessment to 3 months (mRS>2 on admission)
• Dementia known and diagnosed pre-existing at ischemic stroke
• Absolute or relative contraindication to gadolinium injection (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance <15mL/min, pregnant or breastfeeding woman).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immuno-inflammatory profile description in patients with ischemic stroke	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

Primary Outcome Measures

Name	Time	Method
Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment	Up to year	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.