Cerebral Small Vessel DiseaseStrokeStroke RecurrenceBiomarkers
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in White Matter Lesion Volume based on MRI measurements — 1 year MRI: White Matter Lesion volume will be measured and compared over the study trajectory (baseline upon study termination) in mm3
Trial sites (1)
Facility
City
Region
Status
University Hospital Ulm, Department of Neurology, Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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