Clinical trial NCT06342661: Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment
Official title: Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Disease Small Vessel
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We retrospectively enrolled consecutive patients with cardiovascular risk factors from the First Affiliated Hospital of Harbin Medical University.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. The study included 100 subjects, including 50 patients with VCI and 50 normal controls. The diagnosis of VCI was based on the diagnostic criteria for psychiatric disorders in the fifth revised edition of the "Diagnostic and Statistical Manual of Mental Disorders" of the American Psychiatric Association;
2. All relevant examination and cognitive testing work in this study obtained informed consent from the subjects and their families.

Exclusion Criteria:

1. In line with the exclusion criteria for VCI diagnosis in the "Chinese guidelines for the treatment of vascular cognitive impairment 2019"; complicated with autoimmune diseases, blood diseases, malignant tumors, heart, liver, and kidney dysfunction, infectious diseases, family genetic diseases, recent acute or chronic inflammatory diseases, myocardial infarction, etc.; taking antibiotics, steroids, immunosuppressants before the trial; having a history of cranial trauma or surgery.

Primary outcomes:
measure: Patient characteristics
timeFrame: 2023.03.01-2028.11.30
measure: VISTA expression in PBMCs in the VCI and control groups
timeFrame: 2023.03.01-2028.11.30
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: 2023.03.01-2028.11.30 Chi
role: STUDY_CHAIR
References: