Inflammatory faCtors AfteR acUte Ischemic Stroke (ICARUS)

Martin Dichgans

Status

Enrolling

Conditions

Ischemic Stroke

Treatments

Diagnostic Test: immune cell profiling in blood

Diagnostic Test: 3T MRI

Diagnostic Test: [18F]-GE-180 PET

Study type

Interventional

Funder types

Other

Identifiers

NCT04412187

19-428

Details and patient eligibility

About

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.

Full description

The neuroinflammatory response after ischemic brain injury has been identified as a pathomechanism in ischemic stroke. Stroke induces an activation of microglia in the brain, which lasts over months. However, the characteristics and mechanisms of this microglia activation are insufficiently defined.

Our study hypotheses are (i) that a subpopulation of patients with acute stroke develop prominent microglial activation, and (ii) that patients with extensive microglial activation are more likely to experience poor outcome.

Against this background, the investigators set up the "Inflammatory faCtors AfteR acUte ischemic Stroke (ICARUS)" study as an interventional single-centre hospital-based cohort study. N=36 patients with a cortical (N=18) or strictly subcortical (N=18) acute ischemic stroke will be recruited through the local stroke unit (Department of Neurology, LMU Munich). Study participation involves serial TSPO-PET imaging along with serial MR imaging, immune cell profiling in blood, and both clinical and laboratory assessments. Follow-up assessments at 3 weeks, 3 months, 6 months and 12 months will be conducted at the Institute for Stroke and Dementia Research (ISD) and at the Department of Nuclear medicine, both LMU Munich.

Enrollment

36 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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