NCT04412187Recruiting
Inflammatory faCtors AfteR acUte Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
ICARUS is an interventional single-centre hospital-based cohort study in patients admitted to the stroke unit with an acute ischemic stroke. The aims of the study are to i) define the characteristics and determinants of microglial activation after human stroke, and ii) assess the correlation of microglial activation with circulating inflammatory markers, structural brain changes on neuroimaging, and neurological outcomes. ICARUS involves serial TSPO-PET imaging along with serial MRI, immune cell profiling in blood, and both clinical and laboratory assessments in 36 patients with acute ischemic stroke caused by a cortical (N=18) or strictly subcortical (N=18) infarct. In a substudy, the investigators will include 10 independently recruited patients with acute ischemic stroke to assess MRI arterial spin labelling (ASL) sequences as a marker for perfusion measurement of the TSPO tracer.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 22 May 2020
- Start date
- 1 Jul 2020
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Martin Dichgans
- Diseases
- Stroke
- NCT number
- NCT04412187
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 1 Jul 2020 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of stroke, multiple infarcts, infratentorial infarcts affecting the brain stem or cerebellum
- Immunomodulatory therapies within the last 3 months prior stroke
- Infectious diseases within the last 7 days prior stroke
- Contraindications for MRI or PET (pacemaker, aneurysm clip, cochlear implant etc.)
- Radiation exposure of \> 10mSv per year
Other illness
- Known diseases of the CNS other than stroke
- Chronic inflammatory disease
- Conditions interfering with follow-up such as end-stage malignancy
Other
- Unwillingness or inability to give written consent
- Pregnant or breastfeeding women
- Participation in a clinical trial
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Insitute for Stroke and Dementia Research Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Department of Nuclear Medicine Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.