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NCT Number: NCT05473637

Taiwan Associated Genetic and Nongenetic Small Vessel Disease

The TAG-SVD enrolled patients with clinical and neuroimaging features of cerebral small vessel disease (CSVD). All enrolled patients will receive next-generation sequence (NGS) with probes designed to target five candidate CSVD genes, and patients will be divided into genetic or non-genetic groups accordingly. Their clinical features and outcome will be followed for at least 2 years.

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Key information

Conditions

Cerebral Small Vessel Diseases Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Brain Infarction Brain Ischemia CADASIL COL4A1-Related Brain Small Vessel Disease With Haemorrhage Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Infarction Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dementia, Vascular Fabry Disease Genetic Diseases, Inborn Genetic Diseases, X-Linked HTRA1-Related Autosomal Dominant Cerebral Angiopathy Infarction Intracranial Arterial Diseases Ischemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Magnetic Resonance Imaging Metabolic Diseases Metabolism, Inborn Errors Necrosis Nervous System Diseases Next-generation Sequencing Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sphingolipidoses Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must have at least one of the following symptoms/signs or history

  • stroke (especially small vessel occlusion type of ischaemic stroke, spontaneous ICH or young stroke)
  • cognitive impairment or dementia
  • gait disturbance
  • parkinsonism (especially vascular parkinsonism features)
  • headache (especially migraine)
  • positive family history of hereditary CSVD
  • MRI evidence of CSVD (MRI may be done for other reasons), including mild to moderate white matter hyper intensity, any lacune, or any cerebral microbleed

Exclusion criteria

  • MRI evidence of CSVD due to other inflammatory, malignancy, or structural lesions
  • patients or family members not willing to sign informed consent

Treatment and study plan

MRI

Diagnostic Test

Patients will repeat study-protocol MRI at baseline (enrollment) and at least once in 1 year or 2 years follow-up (depends on availability).

Primary outcomes

  1. Number of patients with incident stroke

    Time frame: 2 years

    Clinical stroke, including transient ischemic attack, ischemic stroke, or intracerebral hemorrhage.

    The stroke is defined by a focal neurological deficits lasting more than 24 hours, with accompanied neuroimaging evidence of infarct or hemorrhage in corresponding brain area.

Secondary outcomes

  1. Number of patients with incident dementia

    Time frame: 2 years

    Vascular cognitive impairment (VCI), vascular dementia (VaD), or Alzheimer's dementia or Vascular dementia according to latest diagnostic criteria.

    Alzheimer's disease diagnostic criteria: National Institute of Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease (PMID: 21514247)

    Vascular dementia diagnostic criteria: Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Hao Chen, MD, PhD

CONTACT

[email protected]

886987392027

Sung-Chun Tang, MD, PhD

CONTACT

[email protected]

886972651113

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Deciphering, Construction and Validation of Magnetic Resonance Imaging Maps, Clinical Features and Outcomes in Genetic and Nongenetic Cerebral Small Vessel Diseases

Acronym: TAG-SVD

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
Jul 26, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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