Taiwan Associated Genetic and Nongenetic Small Vessel Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

MRI evidence of CSVD due to other inflammatory, malignancy, or structural lesions

patients or family members not willing to sign informed consent

Trial population

This study enrolled patients with clini-cal and neuroimaging features of CSVD in the neurology outpatient clinic of National Taiwan University Hospital. The clinical features for being enrolled in the TAG-SVD cohort included stroke (especially small vessel occlusion type of ischaemic stroke, spontaneous ICH or young stroke), cognitive impairment, gait disturbance, parkinsonism, headache or a positive family history of hereditary CSVD. The neuroimaging features were at least one evident magnetic resonance imaging (MRI) feature of CSVD

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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).

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Genetic group1 intervention
Group B: Nongenetic group1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with incident stroke

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.

Time frame
2 years

Secondary outcomes

1

Number of patients with incident dementia

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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