Clinical trial Recruiting at 2 sites Interventional Ages 50 and up

Investigating inflammatory factors after acute ischemic stroke

Official title: Inflammatory faCtors AfteR acUte Ischemic Stroke

Run by Ludwig-Maximilians - University of Munich · NCT04412187 · Data updated 2026-11-12

This study is testing how inflammation in the brain after a stroke affects recovery and brain changes in patients who have had an acute ischemic stroke.

Quick facts

Study typeInterventional
Ages50 Years and up
SexAll
Enrollment36 (estimated)
SponsorLudwig-Maximilians - University of Munich
Academic / other
Drugs / interventionsRadiation
Locations2 sites (Munich, Germany and 1 other locations)
StatusRecruiting
StartedJuly 1, 2020
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedApril 4, 2025
Trial IDNCT04412187 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 50 and older who have experienced an acute ischemic stroke within the last 72 hours.

Probably not a fit

Patients with prior strokes, chronic inflammatory diseases, or contraindications for MRI or PET will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ICARUS study is an interventional cohort study focusing on patients admitted to a stroke unit with acute ischemic stroke. It aims to define the characteristics of microglial activation and its correlation with inflammatory markers, brain changes, and neurological outcomes. The study will involve 36 patients undergoing serial TSPO-PET imaging, MRI, and immune cell profiling, with follow-up assessments at multiple intervals. Additionally, a substudy will assess MRI arterial spin labeling in 10 independently recruited patients to measure perfusion related to microglial activation.

Why it matters

Potential benefit: If successful, this study could enhance understanding of neuroinflammation in stroke and improve patient outcomes through targeted therapies.

How similar studies have gone: While the study explores novel aspects of microglial activation in stroke, similar approaches have shown promise in understanding neuroinflammation in other conditions.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 50 years
* Acute ischemic stroke (time frame: \<72 hours) as defined by an acute focal neurological deficit in combination with a corresponding infarct as documented by a diffusion weighted imaging (DWI)-positive lesion on magnetic resonance imaging (MRI); presence of an infarct involving the cortex or a strictly subcortical infarct
* Written informed consent prior to study participation
* Willingness to participate in study assessments including follow-up

Exclusion Criteria:

* Unwillingness or inability to give written consent
* Prior history of stroke, multiple infarcts, infratentorial infarcts affecting the brain stem or cerebellum
* Known diseases of the CNS other than stroke
* Immunomodulatory therapies within the last 3 months prior stroke
* Chronic inflammatory disease
* Infectious diseases within the last 7 days prior stroke
* Conditions interfering with follow-up such as end-stage malignancy
* Contraindications for MRI or PET (pacemaker, aneurysm clip, cochlear implant etc.)
* Radiation exposure of \> 10mSv per year
* Pregnant or breastfeeding women
* Participation in a clinical trial

Where it's running

  • Insitute for Stroke and Dementia Research
    Munich, Germany, Germany
    Recruiting
  • Department of Nuclear Medicine
    Munich, Germany
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.