NCT07660263 Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 300 participants in total. It began in 2026-07-24 with a primary completion date of 2030-12-31.

Brief Summary

To collect large-scale multimodal data, including genomic information, neuroimaging, neurophysiological measures, cognitive assessments, and clinical characteristics from stroke survivors and healthy controls. This study aims to develop and validate an integrated prediction model for identifying individuals at high risk of post-stroke vascular dementia and to establish a foundation for precision medicine approaches in stroke-related cognitive impairment.

Eligibility Criteria

Inclusion Criteria: 1. Healthy Control Group: * Adults aged 19 years or older. * Able to be age- and sex-matched to the stroke cohort. * No history of stroke, transient ischemic attack (TIA), or other central nervous system disorders. * Cognitive function within the normal range for age and education level based on screening assessments (K-MMSE and K-MoCA). * Able to understand the study procedures and provide written informed consent. 2. Stroke Patient Group: * Adults aged 19 years or older. * First-ever ischemic or hemorrhagic stroke confirmed by CT or MRI. * Enrolled in one of the following strata according to time since stroke onset: Stratum A: 7 days to 3 months after stroke onset. Stratum B: \>3 months to 12 months after stroke onset. Stratum C: \>12 months to 36 months after stroke onset. \- Able to understand the study procedures and provide written informed consent, or consent provided by a legally authorized representative when applicable. Exclusion Criteria: 1. Healthy Control Group: * Current severe psychiatric disorders that may affect cognitive function (e.g., major depression, schizophrenia) or use of related medications. * Strong family history of hereditary cerebrovascular disorders (e.g., CADASIL). * Severe medical illness considered inappropriate for study participation. * Any condition that, in the opinion of the investigator, would make participation unsuitable. 2. Stroke Patient Group: * Impaired ability to provide consent (MMSE \<10) without an accompanying caregiver or legally authorized representative. * History of dementia due to causes other than stroke (e.g., Alzheimer's disease) prior to stroke onset. * History of major neurological disorders affecting cognition prior to stroke onset (e.g., Parkinson's disease, brain tumor, multiple sclerosis). * Severe aphasia or impaired consciousness preventing completion of cognitive assessments. * Current or pre-stroke severe psychiatric disorders that may affect cognitive function (e.g., major depression, schizophrenia) or use of related medications. * Strong family history of hereditary cerebrovascular disorders (e.g., CADASIL). * Contraindication to MRI (e.g., metallic implants) or refusal to provide blood samples for genomic analysis. * Any condition that, in the opinion of the investigator, would make participation unsuitable.

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