Observing patients with cerebral small vessel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study collects clinical information, including serum parameters, blood pressure variability, imaging data, and neuropsychological assessments from patients with cerebral small vessel disease (CSVD). The study aims to summarize the clinical and imaging characteristics of the CSVD population, identify novel risk factors, and explore the mechanisms underlying clinical and imaging outcomes. Additionally, it seeks to establish a multivariable prediction model for cognitive and mood disorders in these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants aged between 18 and 80 years, with no restriction on gender.
2. Participants who have completed a 3.0T MRI of the head within one year at Yueyang Hospital, and meet the imaging diagnostic criteria of the 2013 STRIVE guidelines.
3. Participants who have a Modified Rankin Scale (mRS) score of 0-2 (able to perform activities of daily living) at the time of the visit.
4. Participants who are able to understand and agree to participate in the study, and have signed the informed consent form.

Exclusion Criteria:

1. Diagnosis of symptomatic lacunar syndrome without 6 months of onset (participants can be enrolled after 6 months to avoid the impact of the acute phase).
2. Intracranial and extracranial vascular examination confirms stenosis of the blood vessel by ≥50%.
3. Imaging data reveals intracranial space-occupying lesions.
4. A history of other neurological or mental illnesses with a definite diagnosis of the cause, including stroke (excluding lacunar infarctions), neurodegenerative diseases (such as Parkinson's disease and Alzheimer's disease).
5. Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding.
6. Severe impairment in vision, hearing, language function, or limb muscular weakness that prevents completion of relevant tests.
7. Women who are pregnant or breastfeeding.
8. MRI scan contraindicated due to various reasons (such as claustrophobia).
9. Any other reasons that prevent the collection of clinical data required for this study.

Where it's running

• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Jia Zhou — Shanghai University of Traditional Chinese Medicine
• Study coordinator: Yajing Huo
• Email: heej07@126.com
• Phone: +86 188 1821 1605

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.