Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

July 20, 2018 updated by: Chiayi Christian Hospital
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Young stroke

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Young stroke
Patients with acute stroke aged 20 or over, and under 56 years old (Not included 56) .
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fabry disease
Time Frame: 3 years later
The prevalence of Fabry disease in patients with young stroke
3 years later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiayi Christian Hospital

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 20, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fabry Disease

Clinical Trials on GLA gene

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe