Cerebral Small Vessel Disease Progression Dependent on Stroke Type
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohannes Dorst
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Evidence of cerebral small vessel disease on brain MRI, defined as white matter hyperintensities (Fazekas grade 1-3)
cerebral small vessel disease without evidence of an acute ischemic stroke
cerebral small vessel disease with acute lacunar ischemic stroke
Disqualifiers
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
Trial population
Adult patients with sporadic, non-genetic cerebral small vessel disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
180 Participants
are grouped into 3 trial groupsGroup A: Group 1
Group B: Group 2
Group C: Group 3
Trial outcomes
Primary outcomes
1
Change 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 yearSecondary outcomes
1
Changes of Blood Biomarkers
Changes in blood biomarkers (e.g. NfL, GFAP, pTau in pg/ml)
Time frame
1 year2
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 year3
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 year4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johannes Dorst
Lead sponsor
University Hospital Ulm
Sponsor institution
Source ClinicalTrials.gov