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Not yet recruiting NCT04701619

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

No phase Interventional Stroke Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immuno-inflammatory profile description in patients with ischemic stroke.
Who it may be relevant to
Registry conditions: Stroke, Ischemic Stroke. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment [Time frame: Up to year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04701619 · BMR_2020_31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗