Biomarkers, Cerebral Small Vessel Disease, Stroke, Stroke Recurrence
Conditions
Keywords
cerebral small vessel disease, biomarkers, magnetic resonance imaging
Brief 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.
Interventions
None listed
Sponsors
Johannes Dorst
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Blood Biomarkers | 1 year | Changes in blood biomarkers (e.g. NfL, GFAP, pTau in pg/ml) |
| Occurrence of Cerebrovascular Events | 1 year | 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). |
| Changes in Neuropsychological Tests | 1 year | 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. |
| Neurological Functional Abilities | 1 year | Using the modified Rankin Score (0-6, a higher score indicates a worse functional ability and an mRS of 6 indicates death) |
| Changes in Neurovascular Duplex/Dopplerultrasound | 1 year | 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) |
| Stroke Severity | 1 year | National Institutes of Stroke Health Scale (NIHSS, 0-42 points, a higher stroke indicates a more severe stroke) |
| Acitivies of Daily Living | 1 year | ADL Score according to Katz (0-6) |
| EQ5D-5L | 1 year | The EQ5D-5L ranges from a maximum of 1 (full health) to a minimum of roughly -0.661 |
Countries
Germany
Contacts
CONTACTMona E Laible, MD
STUDY_CHAIRMona E Laible, MD
University Hospital Ulm, Germany
Outcome results
None listed