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.
Study Type
OBSERVATIONAL
Enrollment
180
University Hospital Ulm, Department of Neurology, Germany
Ulm, Baden-Wurttemberg, Germany
RECRUITINGChange in White Matter Lesion Volume based on MRI measurements
MRI: White Matter Lesion volume will be measured and compared over the study trajectory (baseline upon study termination) in mm3
Time frame: 1 year
Changes of Blood Biomarkers
Changes in blood biomarkers (e.g. NfL, GFAP, pTau in pg/ml)
Time frame: 1 year
Occurrence of Cerebrovascular Events
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).
Time frame: 1 year
Changes in Neuropsychological Tests
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.
Time frame: 1 year
Neurological Functional Abilities
Using the modified Rankin Score (0-6, a higher score indicates a worse functional ability and an mRS of 6 indicates death)
Time frame: 1 year
Changes in Neurovascular Duplex/Dopplerultrasound
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)
Time frame: 1 year
Stroke Severity
National Institutes of Stroke Health Scale (NIHSS, 0-42 points, a higher stroke indicates a more severe stroke)
Time frame: 1 year
Acitivies of Daily Living
ADL Score according to Katz (0-6)
Time frame: 1 year
EQ5D-5L
The EQ5D-5L ranges from a maximum of 1 (full health) to a minimum of roughly -0.661
Time frame: 1 year
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