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

Primary Purpose

Stroke, Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immuno-inflammatory profile description in patients with ischemic stroke
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Immuno-inflammatory profile description in patients with ischemic stroke

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 25, 2020
    Last Updated
    July 6, 2023
    Sponsor
    Fondation Ophtalmologique Adolphe de Rothschild
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04701619
    Brief Title
    Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies (IMMUNOSTROKE)
    Acronym
    IMMUNOSTROKE
    Official Title
    Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    October 15, 2025 (Anticipated)
    Study Completion Date
    May 15, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondation Ophtalmologique Adolphe de Rothschild

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Ischemic Stroke

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    All patients undergoing a reperfusion procedure as part of an ischemia stroke will be able to participate in the study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Immuno-inflammatory profile description in patients with ischemic stroke
    Arm Type
    Other
    Arm Description
    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
    Intervention Name(s)
    Immuno-inflammatory profile description in patients with ischemic stroke
    Intervention Description
    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 Measure Information:
    Title
    Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment
    Description
    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.
    Time Frame
    Up to year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benjamin Maier
    Phone
    0148036556
    Email
    nmaier@for.paris
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amélie Yavchitz
    Phone
    0148036556
    Email
    ayavchitz@for.paris

    12. IPD Sharing Statement

    Learn more about this trial

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

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