Cerebral Small Vessel Disease Progression Dependent on Stroke Type (ZMA_BIO)
2026年5月20日 更新者：Johannes Dorst
Biomarker-based Assessment of Cerebral Small Vessel Disease Progression After Lacunar and Territorial Stroke - a Prospective Cohort Study
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.
研究概览
研究类型
观察性的
注册 (估计的)
180
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mona E Laible, MD
- 电话号码：+49(0)7311770
- 邮箱：mona.laible@uniklinik-ulm.de
学习地点
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Baden-Wurttemberg
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Ulm、Baden-Wurttemberg、德国、89081
- 招聘中
- University Hospital Ulm, Department of Neurology, Germany
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接触：
- Mona E Laible, MD
- 电话号码：+49(0)731 1770
- 邮箱：mona.laible@uniklinik-ulm.de
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adult patients with sporadic, non-genetic cerebral small vessel disease
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Group 1
cerebral small vessel disease without current stroke
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Group 2
cerebral small vessel disease with acute lacunar stroke
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Group 3
cerebral small vessel disease with acute territorial stroke
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in White Matter Lesion Volume based on MRI measurements
大体时间：1 year
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MRI: White Matter Lesion volume will be measured and compared over the study trajectory (baseline upon study termination) in mm3
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes of Blood Biomarkers
大体时间：1 year
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Changes in blood biomarkers (e.g.
NfL, GFAP, pTau in pg/ml)
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1 year
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Occurrence of Cerebrovascular Events
大体时间：1 year
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Cerebrovascular events during the follow-up period and their association with biomarker levels and MRI-based disease progression, defined as a binary outcome variable (e.g. for ischemic stroke, myocardial infarction, peripheral artery occlusion).
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1 year
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Changes in Neuropsychological Tests
大体时间：1 year
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Neuropsychological assessment focussing on attention, executive function, visual and verbal primary and working memory, as well as visuospatial function.
For interpretation of results, z-scores will be applicable, as they are normalized according to age.
A z-score of 0 equals the mean result of the normative population.
A positive value indicates the data point is above the mean (a better performance than the mean results of the normatove population), while a negative value is below the mean.
A score of -1.5 means the patient is 1.5 standard deviations below the mean, while a +1.0 is one SD above.
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1 year
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Neurological Functional Abilities
大体时间：1 year
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Using the modified Rankin Score (0-6, a higher score indicates a worse functional ability and an mRS of 6 indicates death)
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1 year
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Changes in Neurovascular Duplex/Dopplerultrasound
大体时间：1 year
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Neurovascular Duplex/Dopplerultrasound of extra-/intracranial brain-supplying arteries: changes in Plaque diameters (mm), Intima-Media-Thickness (IMT in mm, a higher IMT is associated with a more severe disease stage)
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1 year
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Stroke Severity
大体时间：1 year
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National Institutes of Stroke Health Scale (NIHSS, 0-42 points, a higher stroke indicates a more severe stroke)
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1 year
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Acitivies of Daily Living
大体时间：1 year
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ADL Score according to Katz (0-6)
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1 year
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EQ5D-5L
大体时间：1 year
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The EQ5D-5L ranges from a maximum of 1 (full health) to a minimum of roughly -0.661
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Mona E Laible, MD、University Hospital Ulm, Germany
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月26日
初级完成 (估计的)
2028年4月1日
研究完成 (估计的)
2028年4月1日
研究注册日期
首次提交
2026年4月13日
首先提交符合 QC 标准的
2026年5月20日
首次发布 (实际的)
2026年5月28日
研究记录更新
最后更新发布 (实际的)
2026年5月28日
上次提交的符合 QC 标准的更新
2026年5月20日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.