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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03384485
Recruitment Status : Unknown
Verified November 2017 by yair levy, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
yair levy, Meir Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Antiphospholipid Syndrome Diagnostic Test: antiphospholipid syndrome Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Lysosomal Hydrolase Alpha-glagtosidase Deficiency in Patients
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
antiphospholipid syndrome
blood test in patients that diagnosed with antiphospholipid syndrome to diagnose Fabry's disease
 Diagnostic Test: antiphospholipid syndrome
blood test for enzyme test,plasma and Lys-3-3 plasma


Outcome Measures
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Primary Outcome Measures :
  1. Lys-3-3 plasma [ Time Frame: an average of 1 year ]
    blood test to find the enzyme for Fabry's disease


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Fabry disease.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384485


Contacts
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Contact: Hitam Hagog 972-09-7472626 Hitam.hagog@clalit.org.il
Contact: Yael Eizikovits 972-09-7471936 yael.eizikovits@clalit.org.il

Locations
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Israel
Meir Medical Center
Kfar Saba, Israel, 44281
Contact: Hitam Hagog    972-09-7472626    Hitam.hagog@clalit.org.il   
Contact: Yael Eizikovits    972-09-7471936    yael.eizikovits@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Yair Levy head of department internal medicin E
More Information
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Responsible Party: yair levy, head of department internal medicine E, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03384485    
Other Study ID Numbers: 0255-17MMC
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Syndrome
Disease
 Pathologic Processes
Autoimmune Diseases
Immune System Diseases