ClinicalTrials.gg
Status unknownNCT03384485Updated Dec 27, 2017

Prevalence of Lysosomal Hydrolase Alpha-glagtosidase Deficiency in Patients With Antiphospholipid Syndrome.

An interventional study of antiphospholipid syndrome in Antiphospholipid Syndrome, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-12-27.

Sponsored by Meir Medical Center · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

the investigators would like to assess the prevalence of Fabry in men and women aged 18-100 who were diagnosed with antiphospholipid syndrome in our departmental clinic in 2000-2017 It is very important to diagnose Fabri that then the treatment of patients can vary dramatically.

The study will include 100 adult patients (18-100) men and women. Testing for the Fabri test in men is an enzyme test and will be performed subject to their consent to sign informed consent. In the women, an enzyme test will be carried out, and the plasma Lys-3-3 plasma storage, as recommended in the recently published diagnostic algorithms, is examined. If diagnosed, a patient will be referred to a genetic institute for further genetic counseling

02

Conditions studied

  • Antiphospholipid Syndrome
03

In context

Antiphospholipid Syndrome

121 studies on the registry are indexed under Antiphospholipid Syndrome; 52 are open to participants now.

This study's planned enrollment of 100 is above the median of 41 across 65 interventional studies indexed under Antiphospholipid Syndrome.

Browse Antiphospholipid Syndrome studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of Antiphospholipid syndrome.
  • able to read and sign inform concent

Exclusion criteria

Exclusion Criteria:

  • Fabry disease.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    antiphospholipid syndrome

    blood test in patients that diagnosed with antiphospholipid syndrome to diagnose Fabry's disease

    Diagnostic Test: antiphospholipid syndrome

Interventions

  • Diagnostic testantiphospholipid syndrome

    blood test for enzyme test,plasma and Lys-3-3 plasma

06

What researchers measure

Primary outcomes

  1. Lys-3-3 plasma

    blood test to find the enzyme for Fabry's disease

    Time frame: an average of 1 year

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2018; primary completion for Aug 2018, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2017
First posted
Dec 27, 2017
StartEst.
Feb 1, 2018
Primary completionEst.
Aug 1, 2018
CompletionEst.
Oct 1, 2018
Last update
Dec 27, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03384485
Responsible party
yair levy (head of department internal medicine E, Meir Medical Center) — Principal investigator
First posted
Dec 27, 2017
Start date
Feb 1, 2018 (estimated)
Primary completion
Aug 1, 2018 (estimated)
Completion
Oct 1, 2018 (estimated)
Last update
Dec 27, 2017

Study contacts

Hitam Hagog
Contact
Hitam.hagog@clalit.org.il
972-09-7472626
Yael Eizikovits
Contact
yael.eizikovits@clalit.org.il
972-09-7471936
Yair Levy
principal investigator · head of department internal medicin E

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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