NCT07611136

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Apr 2028

Study Start

First participant enrolled

March 26, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

April 13, 2026

Last Update Submit

May 20, 2026

Conditions

Cerebral Small Vessel DiseaseStrokeStroke RecurrenceBiomarkers

Keywords

cerebral small vessel diseasebiomarkersmagnetic resonance imaging

Outcome Measures

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

    1 year

Secondary Outcomes (8)

  • Changes of Blood Biomarkers

    1 year

  • Occurrence of Cerebrovascular Events

    1 year

  • Changes in Neuropsychological Tests

    1 year

  • Neurological Functional Abilities

    1 year

  • Changes in Neurovascular Duplex/Dopplerultrasound

    1 year

  • +3 more secondary outcomes

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with sporadic, non-genetic cerebral small vessel disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ulm, Department of Neurology, Germany

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Cerebral Small Vessel DiseasesStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mona E Laible, MD

    University Hospital Ulm, Germany

    STUDY CHAIR

Central Study Contacts

Mona E Laible, MD

CONTACT

+49(0)7311770mona.laible@uniklinik-ulm.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Johannes Dorst

Study Record Dates

First Submitted

April 13, 2026

First Posted

May 28, 2026

Study Start

March 26, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations

DE(1)