Cerebral Small Vessel Disease, Ischemic White Matter Lesions (WMIL), Vascular Cell Adhesion Molecule-1, VCAM-1
Conditions
Brief summary
This prospective study will enroll patients younger than 60 years with ischemic white matter lesions (WMIL) and age-matched healthy controls. We will measure circulating endothelial-related biomarkers, including endothelial progenitor cells (EPCs), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), asymmetric dimethylarginine (ADMA), and homocysteine (Hcy). We will also assess transcription levels of ICAM-1, VCAM-1, and ADMA. All participants will be followed and managed for 2 years, with repeated assessments of endothelial biomarkers and their transcriptional levels, as well as clinical and imaging evaluations. The aims are to characterize changes in endothelial biomarkers in WMIL, to determine how these changes relate to clinical features and imaging progression, and to evaluate whether statins protect endothelial function-by modifying these biomarkers-and thereby help treat WMIL and slow its progression.
Interventions
Oral atorvastatin 10 mg administered once daily at 18:00 (6 p.m.) for 24 months. Dose form: tablet. Route: oral. Indicated for participants with WMH. Adherence monitored by pill count and diary. No dose titration planned.
DRUGPlacebo matching atorvastatin
Placebo tablet matching atorvastatin in appearance and packaging, containing inactive excipients only; taken orally once daily at 18:00 for 24 months.
Sponsors
Suzhou Municipal Hospital of Anhui Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 45-60 years. * Provides written informed consent. * WMIL group: consecutive outpatients/inpatients from the Neurology Department of Suzhou Municipal Hospital, with WMIL confirmed by brain MRI. Diagnostic features: symmetric, diffusely distributed, ill-defined lesions in periventricular and subcortical white matter; iso- or hypointense on T1WI; hyperintense on T2WI and FLAIR. * Control group: healthy individuals aged 45-60 years with brain MRI showing no intracranial lesions.
Exclusion criteria
* Acute intracerebral hemorrhage or acute infarction on brain MRI or CT. * Central nervous system diseases that severely affect cognition, such as Alzheimer's disease or frontotemporal dementia. * White matter lesions due to other causes (e.g., toxic, genetic, immune, infectious, neoplastic, radiation-related). * Severe hepatic, renal, or cardiac insufficiency. * Recent major surgery or severe trauma. * History of psychiatric disorders that would preclude completion of study scales. * Unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VACM1 levels at 0.5, 1.0, 1.5, and 2.0 years | 0.5, 1, 1.5, and 2.0 years after baseline |
Countries
China
Outcome results
None listed