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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Yair Lampl, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01109875
First received: April 22, 2010
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Fabry Disease in the Young Stroke
Other: blood test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • positive screening of fabry disease [ Time Frame: past 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109875

Locations
Israel
Neurology Dept. Edith Wolfson Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
  More Information

No publications provided

Responsible Party: Dr. Yair Lampl, Professor Yair Lampl, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01109875     History of Changes
Other Study ID Numbers: 1
Study First Received: April 22, 2010
Last Updated: June 11, 2014
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Additional relevant MeSH terms:
Fabry Disease
Stroke
Cerebral Infarction
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 23, 2014