NCT01109875

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

June 12, 2014

Status Verified

June 1, 2014

Enrollment Period

4.6 years

First QC Date

April 22, 2010

Last Update Submit

June 11, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • positive screening of fabry disease

    past 5 years

Interventions

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 Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Known diagnosis of stroke or index event due to trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology Dept. Edith Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Yair Lampl

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 23, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2014

Last Updated

June 12, 2014

Record last verified: 2014-06

Locations