Cerebral Small Vessel Disease Progression Dependent on Stroke Type
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Small Vessel Disease, Stroke, Stroke Recurrence, Biomarkers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Biomarker-based Assessment of Cerebral Small Vessel Disease Progression After Lacunar and Territorial Stroke - a Prospective Cohort Study
Overview
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.
Primary outcome measures
- Change in White Matter Lesion Volume based on MRI measurements [Time frame: 1 year]
Secondary outcome measures (8)
- Changes of Blood Biomarkers [Time frame: 1 year]
- Occurrence of Cerebrovascular Events [Time frame: 1 year]
- Changes in Neuropsychological Tests [Time frame: 1 year]
- Neurological Functional Abilities [Time frame: 1 year]
- Changes in Neurovascular Duplex/Dopplerultrasound [Time frame: 1 year]
- Stroke Severity [Time frame: 1 year]
- Acitivies of Daily Living [Time frame: 1 year]
- EQ5D-5L [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital Ulm, Department of Neurology, Germany — Ulm
Identifiers
NCT: NCT07611136 · ZMA_BIO · DRKS00038936