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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WMH - Intervention | Experimental | Participants with WMH receiving oral atorvastatin 10 mg once daily at 18:00 (6 p.m.) for 24 months. Standard assessments will be performed at baseline and follow-up. |
|
| WMH - Placebo | Placebo Comparator | Participants with WMH receiving a placebo tablet matching atorvastatin, administered orally once daily at 18:00 (6 p.m.) for the same duration as the intervention arm. The same assessments will be performed. |
|
| Health Control | No Intervention | Health control participants with no study intervention; baseline and follow-up assessments only over the same schedule as patient groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 10 mg daily | Drug | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Hospital of Anhui Medical University | Suzhou | Anhui | 234000 | China |
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| ID | Term |
|---|---|
| D059345 | Cerebral Small Vessel Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo matching atorvastatin | Drug | Placebo tablet matching atorvastatin in appearance and packaging, containing inactive excipients only; taken orally once daily at 18:00 for 24 months. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |