Observing patients with cerebral small vessel disease

Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease

This study looks at patients with cerebral small vessel disease to gather information about their health and brain scans to better understand the condition and find ways to predict mood and thinking problems.

Quick facts

• Study type: Observational
• Enrollment: 1078 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05985213 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 80 years who have undergone a 3.0T MRI of the head and meet specific imaging diagnostic criteria for CSVD.

Not a fit: Patients with acute symptomatic lacunar syndrome, significant vascular stenosis, or other neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of cognitive and emotional disorders in patients with cerebral small vessel disease.

How similar studies have performed: Other studies have shown promise in understanding cerebral small vessel disease, but this approach may provide novel insights into risk factors and predictive modeling.

Eligibility criteria

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 this trial is running

Shanghai

• 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

Conditions: Cerebral Small Vessel Diseases