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

February 15, 2024 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
Up to year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

May 15, 2026

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)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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