Viewing Study NCT00414583



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00414583
Status: COMPLETED
Last Update Posted: 2021-04-09
First Post: 2006-12-19

Brief Title: Stroke in Young Fabry Patients sifap1 Frequency of Fabry Disease in Young Stroke Patients
Sponsor: CENTOGENE GmbH Rostock
Organization: CENTOGENE GmbH Rostock

Study Overview

Official Title: Stroke in Young Fabry Patients sifap1 Frequency of Fabry Disease in an Unselected Group of Young Stroke Patients an International Multicentre Prevalence Study
Status: COMPLETED
Status Verified Date: 2020-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: sifap1
Brief Summary: More than one million people in Europe suffer from a stroke every day Normally older people have a stroke but also a significant number of younger people between 18 and 55 years Usually these cannot be explained by the classical risk factors such as diabetes overweight and high blood pressure New studies indicate that in about 1 - 2 of the younger stroke patients the cause could have been an undiagnosed genetic disease the so called Fabry disease The purpose of this study is to determine in a large number of young stroke patients how many strokes were caused by Fabry Disease
Detailed Description: Aim

To determine the frequency of Fabry disease in an unselected group of young patients 18 - 55 years of age with acute cerebrovascular event CVE

Fabry disease and stroke

Rolfs and co-workers have shown a high frequency of Fabry disease in a cohort of patients with cryptogenic stroke 4 28721 aged between 18 and 55 years This corresponds to about 12 in the general population of young stroke patients Therefore the authors stated that Fabry disease must be considered in all cases of unexplained stroke in young patients especially in cases with the combination of infarction in the vertebrobasilar artery system and proteinuria

Cryptogenic strokes are cerebrovascular lesions of unknown origin Clinical and laboratory data show that Fabry disease is itself a risk factor for accelerated atherosclerosis and cardiac and renal disease which can lead to emboli and hypertension The pilot-phase started April 2007 the official study started January 2008

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None