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NCT Number: NCT07611136

Cerebral Small Vessel Disease Progression Dependent on Stroke Type

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.

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Key information

Conditions

Cerebral Small Vessel Disease Biomarkers Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Stroke Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ulm, Department of Neurology, Germany

Ulm, Baden-Wurttemberg, 89081, Germany

Location status: Recruiting

Location contact

Mona E Laible, MD

CONTACT

[email protected]

+49(0)731 1770

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in White Matter Lesion Volume based on MRI measurements

    Time frame: 1 year

    MRI: White Matter Lesion volume will be measured and compared over the study trajectory (baseline upon study termination) in mm3

Secondary outcomes

  1. Changes of Blood Biomarkers

    Time frame: 1 year

    Changes in blood biomarkers (e.g. NfL, GFAP, pTau in pg/ml)

  2. Occurrence of Cerebrovascular Events

    Time frame: 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).

  3. Changes in Neuropsychological Tests

    Time frame: 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.

  4. Neurological Functional Abilities

    Time frame: 1 year

    Using the modified Rankin Score (0-6, a higher score indicates a worse functional ability and an mRS of 6 indicates death)

  5. Changes in Neurovascular Duplex/Dopplerultrasound

    Time frame: 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)

  6. Stroke Severity

    Time frame: 1 year

    National Institutes of Stroke Health Scale (NIHSS, 0-42 points, a higher stroke indicates a more severe stroke)

  7. Acitivies of Daily Living

    Time frame: 1 year

    ADL Score according to Katz (0-6)

  8. EQ5D-5L

    Time frame: 1 year

    The EQ5D-5L ranges from a maximum of 1 (full health) to a minimum of roughly -0.661

Study contacts

Contact information is provided by the study sponsor or research team.

Mona E Laible, MD

CONTACT

[email protected]

+49(0)7311770

Sponsors and collaborators

Lead sponsor

Johannes Dorst

Other

Registry information

Official study title

Biomarker-based Assessment of Cerebral Small Vessel Disease Progression After Lacunar and Territorial Stroke - a Prospective Cohort Study

Acronym: ZMA_BIO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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