Cerebral Small Vessel Disease Progression Dependent on Stroke Type (ZMA_BIO)

Johannes Dorst

Status: Enrolling

Conditions: Cerebral Small Vessel Disease; Biomarkers; Stroke; Stroke Recurrence

Study type: Observational

Funder types: Other

Identifiers

NCT07611136

DRKS00038936 (Other Identifier)

ZMA_BIO

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 3 patient groups

Group 1

Description:

cerebral small vessel disease without current stroke

Group 2

Description:

cerebral small vessel disease with acute lacunar stroke

Group 3

Description:

cerebral small vessel disease with acute territorial stroke