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

NCT ID: NCT03384485

Last Updated: 2017-12-27

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-10-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Antiphospholipid Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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antiphospholipid syndrome

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

Group Type OTHER

antiphospholipid syndrome

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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antiphospholipid syndrome

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• Fabry disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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yair levy

head of department internal medicine E

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yair Levy

Role: PRINCIPAL_INVESTIGATOR

head of department internal medicin E

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Hitam Hagog

Role: CONTACT

Phone: 972-09-7472626

Email: [email protected]

Yael Eizikovits

Role: CONTACT

Phone: 972-09-7471936

Email: [email protected]

Facility Contacts

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Hitam Hagog

Role: primary

Yael Eizikovits

Role: backup

Other Identifiers

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0255-17MMC

Identifier Type: -

Identifier Source: org_study_id