Actively Recruiting
Biomarker-based Assessment of Cerebral Small Vessel Disease Progression After Lacunar and Territorial Stroke - a Prospective Cohort Study
Led by Johannes Dorst · Updated on 2026-05-28
180
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying cerebral small vessel disease (CSVD) to understand how its development varies depending on the type of stroke a patient has experienced. This prospective observational study focuses on adults with known or newly diagnosed CSVD as seen on MRI scans. It aims to see if blood-based biomarkers, including some specific to the central nervous system, can provide additional insight into the progression of CSVD. The study also examines patient-important outcomes like cognitive abilities, neurological function, quality of life, and risk of stroke recurrence. Participants will be grouped based on MRI findings into those with CSVD without stroke, with acute lacunar ischemic stroke, or with acute territorial ischemic stroke. This study does not involve treatments but follows these groups over time to observe disease progression. Assessments include MRI evaluations and blood tests for biomarkers, along with various neurological and quality of life tests. During the study, participants will undergo MRI scans to measure changes in white matter lesions over one year. They will also have blood samples taken to track biomarker changes and assessments for neuropsychological performance, neurological function, stroke severity, daily activities, and quality of life. Researchers will monitor for any new cerebrovascular events and use ultrasound imaging to study neurovascular changes. The total participation lasts one year with regular follow-up visits to collect this information.
CONDITIONS
Brief Title
Cerebral Small Vessel Disease Progression Dependent on Stroke Type
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Evidence of cerebral small vessel disease on brain MRI, defined as white matter hyperintensities (Fazekas grade 1-3)
- Assigned to one of these groups based on MRI findings: CSVD without acute ischemic stroke, CSVD with acute lacunar ischemic stroke, or CSVD with acute territorial ischemic stroke
- Able to provide written informed consent
- Sufficient German language skills to understand study procedures and assessments
You will not qualify if you...
- White matter hyperintensities caused by conditions other than cerebral small vessel disease (e.g., inflammatory CNS disorders, leukodystrophies, brain tumors)
- Known neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or other dementias
- Recent or acute traumatic brain injury
- Contraindications to MRI scanning
- Pregnancy or breastfeeding
- Life expectancy less than one year
- Unable to comply with study procedures or follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants undergo assessments including MRI, blood biomarkers, neuropsychological tests, and neurological evaluations to observe cerebral small vessel disease progression.
Multiple visits over 1 year
Trial Site Locations
Total: 1 location
1
University Hospital Ulm, Department of Neurology, Germany
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
Research Team
M
Mona E Laible, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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