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

NCT06342661 | Recruiting

• 1 other identifier: 2022IIT205
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disease Small Vessel

Outcome Measures

Primary Outcomes (2)

• Patient characteristics

  2023.03.01-2028.11.30

• VISTA expression in PBMCs in the VCI and control groups

  2023.03.01-2028.11.30

Study Arms (2)

Control

Diagnostic Test: Neuropsychological testing

Case

Diagnostic Test: Neuropsychological testing

Interventions

Neuropsychological testing DIAGNOSTIC_TEST

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)

Case; Control

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We retrospectively enrolled consecutive patients with cardiovascular risk factors from the First Affiliated Hospital of Harbin Medical University.

You may qualify if:

• 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;
• All relevant examination and cognitive testing work in this study obtained informed consent from the subjects and their families.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150010, China

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 2023.03.01-2028.11.30 Chi

  First Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

Central Study Contacts

Dan Liu

CONTACT

15145086350; liudan19911214@126.com

LiJun Chi

CONTACT

13895783757; clj3757@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: March 1, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

CN (1)