Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

NCT ID: NCT03596398

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2022-01-31

Brief Summary

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Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Detailed Description

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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.

Conditions

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Fabry Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Young stroke

Patients with acute stroke aged 20 or over, and under 56 years old (Not included 56) .

GLA gene

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Chiayi Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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105028

Identifier Type: -

Identifier Source: org_study_id

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