Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Wolfson Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Wolfson Medical Center
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01109875
First received: April 22, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 22, 2010 | ||||
| Last Updated Date | April 22, 2010 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
positive screening of fabry disease [ Time Frame: past 5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to determine the incidence of Fabry Disease in young stroke patients in an Israeli stroke clinic. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
||||
| Condition ICMJE | Fabry Disease in the Young Stroke | ||||
| Intervention ICMJE | 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). |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 - |
||||
| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01109875 | ||||
| Other Study ID Numbers ICMJE | 1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Prof. Yair Lampl, Wolfson Medical Center | ||||
| Study Sponsor ICMJE | Wolfson Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Wolfson Medical Center | ||||
| Verification Date | April 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||