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Clinical Validation and Evaluation of an Automatic White Matter Hyperintensity Recognition System for Early Warning of Vascular Cognitive Impairment

Clinical Validation and Evaluation of an Automatic White Matter Hyperintensity Recognition System for Early Warning of Vascular Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113015
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-11-25
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular mild cognitive impairment (VMCI)

Interventions

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Hypertensive patients aged 50 to 80 years. 2.Presence of ischemic white matter hyperintensities (WMH) on cranial magnetic resonance imaging (MRI). 3.No history of central nervous system diseases such as stroke, head trauma, encephalitis, hydrocephalus, epilepsy, Parkinson's disease, Alzheimer's disease, frontotemporal dementia, or Lewy body dementia, and no systemic diseases known to cause cognitive impairment. 4.No history of congenital mental retardation or psychiatric disorders such as anxiety or depression. 5.Not taking any medications that affect cognitive function. 6.Ability to cooperate with completing cognitive assessments [a Mini-Mental State Examination (MMSE) score of >13 for illiterate individuals, >19 for those with primary school education, and >24 for those with a junior high school education or above]. 7.Provision of signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Presence of WMH from non-vascular origins, such as multiple sclerosis, sarcoidosis, cerebral radiation therapy, or leukodystrophies. 2.Presence of non-lacunar infarcts (cortical and/or subcortical) or cerebral hemorrhage. 3.Cranial MRI clearly indicating cortical or hippocampal atrophy. 4.Cognitive impairment attributable to other neurodegenerative diseases, such as Alzheimer's disease, Lewy body dementia, frontotemporal dementia, or Parkinson's disease. 5.Other cerebral pathologies, including tumors, hydrocephalus, trauma, neurosyphilis, acquired immunodeficiency syndrome (AIDS), or Creutzfeldt-Jakob disease. 6.Severe psychiatric disorders, epilepsy, alcohol or substance abuse, poisoning, or metabolic abnormalities. 7.Individuals with no abnormalities detected on cranial MRI or those unable to undergo or complete the MRI examination.

Design outcomes

Primary

MeasureTime frame
Sensitivity;

Countries

China

Contacts

Public ContactZhang Hui

Shandong Provincial Third Hospital

xtgdzh@163.com+86 531 81656367

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026