Investigating inflammatory factors after acute ischemic stroke
Inflammatory faCtors AfteR acUte Ischemic Stroke
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Ludwig-Maximilians - University of Munich Academic / other |
| Drugs / interventions | Radiation |
| Locations | 2 sites (Munich, Germany and 1 other locations) |
| Trial ID | NCT04412187 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older who have experienced an acute ischemic stroke within the last 72 hours.
Not a fit: Patients with prior strokes, chronic inflammatory diseases, or contraindications for MRI or PET will not benefit from this study.
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 performed: While the study explores novel aspects of microglial activation in stroke, similar approaches have shown promise in understanding neuroinflammation in other conditions.
Eligibility criteria
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 this trial is running
Munich, Germany and 1 other locations
- Insitute for Stroke and Dementia Research — Munich, Germany, Germany (Recruiting)
- Department of Nuclear Medicine — Munich, Germany (Recruiting)
Study contacts
- Principal investigator: Martin Dichgans, Prof. — LMU Munich
- Study coordinator: Martin Dichgans, Prof.
- Email: martin.dichgans@med.uni-muenchen.de
- Phone: +49 4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.