NCT06342661

Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: First Affiliated Hospital of Harbin Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

1\. Explore the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. Discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. Explore the correlation between different immune inflammatory factors (IL1, IL6, IL10, INFγ, TNFα) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients; 4. Track and explore the dynamic changes of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years.

Detailed description

The prospective observational study design was adopted to screen patients with cardiovascular risk factors who visited the Department of Neurology in the First Hospital of Harbin Medical University since November 2022. The patients mainly categorize into two groups: without cognitive impairment (control) and with cognitive impairment (VCI).. General information, imaging, functional assessment, immune checkpoint VISTA in peripheral blood and cerebrospinal fluid, and blood-related indicators were collected. Some patients who could cooperate were followed up for 3-5 years. By analyzing the correlation between the content of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid, disease risk factors, imaging, functional scores and blood indicators, the relationship between immune checkpoints and nervous system diseases was better understood.

Conditions

• Cerebrovascular Disease Small Vessel

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Neuropsychological testing	The primary outcomes were Mini-Mental State Examination and Montreal Cognitive Assessment scores for screening of cognitive decline, which are recommended by NINDS-AIREN. The secondary outcomes included the performance in five cognition domains: (1) verbal memory, Hopkins Verbal Learning Test ; (2) visual-spatial ability, Clock Drawing test; (3) executive function, Trail Making test (TMT) (B time); (4) attention, TMT (A time); and (5) language tests, Boston Naming test2 (BNT-2)

Timeline

• Start date: 2023-03-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-04-02
• Last updated: 2024-04-02

Locations

1 site across 1 country: China