Taiwan Associated Genetic and Nongenetic Small Vessel Disease

Stroke Clinical Trial

— TAG-SVD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473637
• Other study ID #: 201911029RINB
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: Sung-Chun Tang, MD, PhD
• Phone: 886972651113
• Email: sctang[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cadasil
• Cerebral Small Vessel Diseases
• Fabry Disease
• Hemorrhage
• Magnetic Resonance Imaging
• Next-generation Sequencing
• Stroke

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Neurology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Chen CH, Chu YT, Chen YF, Ko TY, Cheng YW, Lee MJ, Chen PL, Tang SC, Jeng JS. Comparison of clinical and neuroimaging features between NOTCH3 mutations and nongenetic spontaneous intracerebral haemorrhage. Eur J Neurol. 2022 Nov;29(11):3243-3254. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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	2 years