Biomarker-based Assessment of Cerebral Small Vessel Disease Progression After Lacunar and Territorial Stroke - a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
研究概览
简要总结
The goal of this prospective, observational study is to understand if cerebral small vessel disease (CSVD) has different velocities and patterns of temporal development, dependent on a concurrent ischemic stroke. It focusses on adult patients with known or newly diagnosed CSVD on magnetic resonance imaging. The study will evaluate if blood based, in parts central nervous system specific protein markers, so called biomarkers, have an additional value reflecting the course of CSVD as defined per MRI assessments. Further patient-relevant endpoints include neuropsychological abilities, neurological functional outcomes, quality of life assessments, stroke recurrence risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Evidence of cerebral small vessel disease on brain MRI, defined as white matter hyperintensities (Fazekas grade 1-3)
- •Assignment to one of the following study groups based on MRI findings:
- •cerebral small vessel disease without evidence of an acute ischemic stroke
- •cerebral small vessel disease with acute lacunar ischemic stroke
- •cerebral small vessel disease with acute territorial ischemic stroke
- •Ability to provide written informed consent
- •Sufficient German language skills to understand study procedures and assessments
排除标准
- •Alternative plausible causes of white matter hyperintensities other than cerebral small vessel disease (e.g. inflammatory central nervous system disorders, leukodystrophies, brain tumors)
- •Known neurodegenerative diseases (e.g. Parkinson's disease, Alzheimer's disease, other dementias)
- •Acute or recent traumatic brain injury
- •Contraindications to magnetic resonance imaging
- •Pregnancy or breastfeeding
- •Life expectancy of less than one year
- •Inability to comply with study procedures or follow-up visits
研究者
Johannes Dorst
Prof. Dr. Johannes Dorst
University Hospital Ulm
