Inflammatory faCtors AfteR acUte Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- microglia activation in patients with acute stroke
研究概览
简要总结
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.
详细描述
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.
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. These patients will receive dynamic PET in addition to the ASL sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TSPO PET imaging
All study participants will receive [18F]-GE-180, i.e. TSPO PET imaging to assess microglia activation.
干预措施: [18F]-GE-180 PET (Diagnostic Test)
TSPO PET imaging
All study participants will receive [18F]-GE-180, i.e. TSPO PET imaging to assess microglia activation.
干预措施: 3T MRI (Diagnostic Test)
TSPO PET imaging
All study participants will receive [18F]-GE-180, i.e. TSPO PET imaging to assess microglia activation.
干预措施: immune cell profiling in blood (Diagnostic Test)
结局指标
主要结局
microglia activation in patients with acute stroke
时间窗: 3 months after acute ischemic stroke
Microglia activation will be assessed using TSPO PET imgaing.
functional outcome in patients after acute ischemic stroke
时间窗: 12 months after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
cognitive outcome in patients after acute ischemic stroke
时间窗: 12 months after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
次要结局
- 3T MR imaging(12 months after acute ischemic stroke)
- inflammatory markers in blood(3 months after acute ischemic stroke)
- Duplex ultrasound(6 months after acute ischemic stroke)
研究者
Martin Dichgans
Prof. Dr. Martin Dichgans
Ludwig-Maximilians - University of Munich