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NCT03596398 Clinical Trial

Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Fabry Disease Clinical Trial

Official title:
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03596398
Other study ID # 105028
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date January 31, 2022

Study information
Verified date July 2018
Source Chiayi Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Description:

This is a cross-sectional, population-based study. No randomization procedure will be executed in this study. Approximately 1000 subjects over a 36-month period. The aim of this screening study is to identify the Fabry disease as the cause in patients with young stroke.

To measure the level of α-Gal A activity, male subjects will initially provide a DBS sample and female subjects will start with a test by whole blood sample.

The prevalence of Fabry disease among patients with young stroke will be estimated by a confirmative diagnosis in gene testing.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1000
Est. completion date January 31, 2022
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria:

- Patients aged 20 or over

- Patients aged under 56 years old, not included 56

- Patients with acute stroke

- Patients and/or their legal representatives are willing to provide written informed consent

Exclusion Criteria:

- Patients with a confirmed diagnosis of Fabry disease

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• GLA gene
Genetic test will be performed when enzyme activity is found abnormal in the whole blood test or confirmation is required. 5 ml of blood sample will be obtained and polymerase chain reaction (PCR) sequencing will be executed to determine mutations in the GLA gene.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Chiayi Christian Hospital Sanofi

Outcome
Type Measure Description Time frame Safety issue
Primary Fabry disease The prevalence of Fabry disease in patients with young stroke 3 years later
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