An observational study in Cerebral Small Vessel Disease, Stroke and Stroke Recurrence, sponsored by Johannes Dorst. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Johannes Dorst · Observational
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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.
128 studies on the registry are indexed under Cerebral Small Vessel Diseases; 71 are open to participants now.
This study's planned enrollment of 180 is below the median of 260 across 56 observational studies indexed under Cerebral Small Vessel Diseases.
Browse Cerebral Small Vessel Diseases studies →This is the only study on the registry with Johannes Dorst as lead sponsor.
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Adult patients with sporadic, non-genetic cerebral small vessel disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cerebral small vessel disease without current stroke
cerebral small vessel disease with acute lacunar stroke
cerebral small vessel disease with acute territorial stroke
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 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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Apr 2028, 24 months after the start.
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Cerebral Small Vessel Diseases →