Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-03 @ 8:15 PM
Study NCT ID:
NCT06342661
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Disease Small Vessel']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We retrospectively enrolled consecutive patients with cardiovascular risk factors from the First Affiliated Hospital of Harbin Medical University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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;\n2. All relevant examination and cognitive testing work in this study obtained informed consent from the subjects and their families.\n\nExclusion Criteria:\n\n1\\. 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.'}, 'identificationModule': {'nctId': 'NCT06342661', 'briefTitle': 'Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment', 'orgStudyIdInfo': {'id': '2022IIT205'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'interventionNames': ['Diagnostic Test: Neuropsychological testing']}, {'label': 'Case', 'interventionNames': ['Diagnostic Test: Neuropsychological testing']}], 'interventions': [{'name': 'Neuropsychological testing', 'type': 'DIAGNOSTIC_TEST', 'description': '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)', 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150010', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LiJun Chi', 'role': 'CONTACT', 'email': 'clj3757@163.com', 'phone': '13895783757'}], 'facility': 'First Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Dan Liu', 'role': 'CONTACT', 'email': 'liudan19911214@126.com', 'phone': '15145086350'}, {'name': 'LiJun Chi', 'role': 'CONTACT', 'email': 'clj3757@163.com', 'phone': '13895783757'}], 'overallOfficials': [{'name': '2023.03.01-2028.11.30 Chi', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Harbin Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}