NCT03596398

Brief Summary

Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

5.8 years

First QC Date

June 15, 2018

Last Update Submit

July 20, 2018

Conditions

Fabry Disease

Keywords

Fabry diseaseYoung stroke

Outcome Measures

Primary Outcomes (1)

  • Fabry disease

    The prevalence of Fabry disease in patients with young stroke

    3 years later

Study Arms (1)

Young stroke

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

Genetic: GLA gene

Interventions

GLA geneGENETIC

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.

Young stroke

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young stroke

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a confirmed diagnosis of Fabry disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

Dried blood spot (DBS) sample and whole blood sample.

MeSH Terms

Conditions

Fabry Disease

Interventions

alpha-Galactosidase

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

GalactosidasesGlycoside HydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

July 23, 2018

Study Start

January 1, 2016

Primary Completion

September 30, 2021

Study Completion

January 31, 2022

Last Updated

July 23, 2018

Record last verified: 2018-07