Cerebrovascular Disease Small VesselNCT06342661
Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment
An observational study of Cerebrovascular Disease Small Vessel, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cerebrovascular Disease Small Vessel
- What is being tested?
- Neuropsychological testing
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We retrospectively enrolled consecutive patients with cardiovascular risk factors from the First Affiliated Hospital of Harbin Medical University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150010
LiJun Chi, 13895783757, clj3757@163.com
About this study
- 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.
Read the 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
- Being tested
- Neuropsychological testing
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Diagnostic Test: Neuropsychological testing | |
| Case | Not described Receives: Diagnostic Test: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics
Measured: 2023.03.01-2028.11.30
VISTA expression in PBMCs in the VCI and control groups
Measured: 2023.03.01-2028.11.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Mar 2023
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular Disease Small VesselStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 2023.03.01-2028.11.30 Chi, Study chair, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342661
- Sponsor's protocol ID
- 2022IIT205
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06342661
- Acronym / sponsor ID
- 2022IIT205
- Conditions
- Cerebrovascular Disease Small Vessel
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Neuropsychological testing |
| Case | – | Diagnostic Test: Neuropsychological testing |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We retrospectively enrolled consecutive patients with cardiovascular risk factors from the First Affiliated Hospital of Harbin Medical University.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingThe 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) | Diagnostic test | Case, Control |
Primary outcome
Patient characteristics
Time frame: 2023.03.01-2028.11.30
VISTA expression in PBMCs in the VCI and control groups
Time frame: 2023.03.01-2028.11.30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2023.03.01-2028.11.30 Chi study chair
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disease Small Vessel, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Liu (15145086350, liudan19911214@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient characteristics (time frame: 2023.03.01-2028.11.30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.