Cerebral Small Vessel DiseaseZMA_BIONCT07611136
Cerebral Small Vessel Disease Progression Dependent on Stroke Type
An observational study of Cerebral Small Vessel Disease and Stroke, run by Johannes Dorst at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Small Vessel Disease, Stroke, Stroke Recurrence
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 26 Mar 2026to 1 Apr 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with sporadic, non-genetic cerebral small vessel disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Ulm, Department of Neurology, Germany
Ulm, Baden-Wurttemberg, 89081
Mona E Laible, MD, +49(0)731 1770, mona.laible@uniklinik-ulm.de
About this study
Official title: Biomarker-based Assessment of Cerebral Small Vessel Disease Progression After Lacunar and Territorial Stroke - a Prospective Cohort Study
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.
- Conditions
- Cerebral Small Vessel Disease, Stroke, Stroke Recurrence, Biomarkers
- Keywords
- cerebral small vessel disease, biomarkers, magnetic resonance imaging
- Medical subject headings
- Cerebral Small Vessel Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | cerebral small vessel disease without current stroke | |
| Group 2 | cerebral small vessel disease with acute lacunar stroke | |
| Group 3 | cerebral small vessel disease with acute territorial stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (8)
Changes of Blood Biomarkers
Changes in blood biomarkers (e.g. NfL, GFAP, pTau in pg/ml)
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 1 year
Stroke Severity
National Institutes of Stroke Health Scale (NIHSS, 0-42 points, a higher stroke indicates a more severe stroke)
Measured: 1 year
Acitivies of Daily Living
ADL Score according to Katz (0-6)
Measured: 1 year
EQ5D-5L
The EQ5D-5L ranges from a maximum of 1 (full health) to a minimum of roughly -0.661
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start26 Mar 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Johannes Dorst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johannes Dorst, University Hospital Ulm
- Investigators
- Mona E Laible, MD, Study chair, University Hospital Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611136
- Sponsor's protocol ID
- ZMA_BIO
- Other IDs
- DRKS00038936
- Acronym
- ZMA_BIO
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided