Prevalence of Lysosomal Hydrolase Alpha-glagtosidase Deficiency in Patients With Antiphospholipid Syndrome.
1 other identifier
interventional
100
1 country
1
Brief Summary
Fabry disease, an X-linked disorder of glycosphingolipids that is caused by mutations of the GLA gene that codes for α-galactosidase A, leads to dysfunction of many cell types and includes a systemic vasculopathy. As a result, patients have a markedly increased risk of developing ischemic stroke, small-fiber peripheral neuropathy, cardiac dysfunction and chronic kidney disease. Because this disease is a rare disease most of the time it is misdiagnosed, so in this study we will check out the Prevalence of lysosomal hydrolase alpha-glagtosidase deficiency ( Fabry disease) in patients with Antiphospholipid Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 27, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedDecember 27, 2017
November 1, 2017
6 months
November 28, 2017
December 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Lys-3-3 plasma
blood test to find the enzyme for Fabry's disease
an average of 1 year
Study Arms (1)
antiphospholipid syndrome
OTHERblood test in patients that diagnosed with antiphospholipid syndrome to diagnose Fabry's disease
Interventions
blood test for enzyme test,plasma and Lys-3-3 plasma
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Antiphospholipid syndrome.
- able to read and sign inform concent
You may not qualify if:
- Fabry disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Medical Center
Kfar Saba, 44281, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yair Levy
head of department internal medicin E
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of department internal medicine E
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 27, 2017
Study Start
February 1, 2018
Primary Completion
August 1, 2018
Study Completion
October 1, 2018
Last Updated
December 27, 2017
Record last verified: 2017-11