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NCT01109875 Clinical Trial

Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic

Fabry Disease in the Young Stroke Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01109875
Other study ID # 1
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 22, 2010
Last updated June 11, 2014
Start date May 2010

Study information
Verified date June 2014
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the incidence of Fabry Disease in young stroke patients in an Israeli stroke clinic.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

diagnosis of stoke or TIA Time period within last 5 years -

Exclusion Criteria:

Known diagnosis of stroke or index event due to trauma

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• blood test
Dry blood spots (DBS) analysis of a- galactosidase-A activity will be used for male patients' diagnosis. Males and females with enzymatic activity bellow the test's cut-off will be further diagnosed by gene sequencing. Since females are heterozygote and may have high residual levels of active enzyme, female patients with a- galactosidase-A activity of 30% bellow averaged normal range will also be further diagnosed by gene sequencing as described before (8).

Locations
Country Name City State
Israel Neurology Dept. Edith Wolfson Medical Center Holon

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary positive screening of fabry disease past 5 years No