ClinicalTrials.gov record NCT05473637
Taiwan Associated Genetic and Nongenetic Small Vessel Disease
Deciphering, Construction and Validation of Magnetic Resonance Imaging Maps, Clinical Features and Outcomes in Genetic and Nongenetic Cerebral Small Vessel Diseases
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective observational cohort study of people with clinical or MRI features of cerebral small vessel disease (CSVD). All participants receive targeted next-generation gene sequencing and repeat MRI; participants are grouped as genetic or non-genetic based on the sequencing results. Clinical features and outcomes are followed for at least two years.
What it is studying. The study investigates how MRI findings and clinical features relate to genetic versus non-genetic forms of cerebral small vessel disease, and how these groups differ in outcomes such as new strokes or dementia over a two-year period.
What the researchers hope to learn. To build and validate MRI maps linked to clinical features, to describe differences between genetic and non-genetic CSVD, and to measure rates of incident stroke and dementia over two years.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Diagnostic test
- MRI
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
At enrollment participants will have study‑protocol MRI and will undergo next‑generation sequencing (NGS) testing focusing on five candidate CSVD genes (NOTCH3, HTRA1, GLA, TREX1, COL4A1). MRI will be repeated at least once during follow-up (around 1 or 2 years depending on availability). Clinical features and outcomes (including new strokes and cognitive status) will be followed for at least 2 years. Participants will be classified into genetic or nongenetic groups based on the NGS results.
How the study is structured. Prospective observational cohort. Participants have targeted next-generation sequencing for five candidate CSVD genes and a study MRI at enrollment, with at least one repeat MRI during follow-up (around 1–2 years). Participants are divided into genetic or non-genetic groups based on sequencing results and are followed for clinical outcomes for at least two years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Taiwan. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Fabry disease
Important dates
- Study start
- Jan 1, 2019
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2028 (estimated)
- Target enrollment
- 500 participants (estimated)
- Last updated on registry
- Jan 20, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- National Taiwan University Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Sung-Chun Tang, MD, PhD 📞 886972651113 ✉ sctang@ntuh.gov.tw
- Chih-Hao Chen, MD, PhD 📞 886987392027 ✉ antonychen@ntu.edu.tw
Participating sites (1)
- Department of Neurology, National Taiwan University HospitalRecruiting
Taipei, 100 · Taiwan
- Sung-Chun Tang, MD, PhD · 886972651113 · sctang@ntuh.gov.tw
- Chih-Hao Chen, MD, PhD · 886987392027 · antonychen@ntu.edu.tw
Terms used on this page · explanations by MedicalUpdates.ai
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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