Back to resultsScreening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic
Primary Purpose
Fabry Disease in the Young Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
blood test
Sponsored by
About this trial
This is an interventional diagnostic trial for Fabry Disease in the Young Stroke
Eligibility Criteria
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
-
Sites / Locations
- Neurology Dept. Edith Wolfson Medical Center
Outcomes
Primary Outcome Measures
positive screening of fabry disease
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01109875
Brief Title
Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the incidence of Fabry Disease in young stroke patients in an Israeli stroke clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fabry Disease in the Young Stroke
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
blood test
Intervention Description
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).
Primary Outcome Measure Information:
Title
positive screening of fabry disease
Time Frame
past 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Facility Information:
Facility Name
Neurology Dept. Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic
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