NCT00414583

Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in Young Stroke Patients

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
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (actual)
• Sponsor: CENTOGENE GmbH Rostock · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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 % \[28/721\]) aged between 18 and 55 years. This corresponds to about 1.2 % 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.

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
OTHER	No intervention	Observational study, only laboratory analysis and diagnostic interventions done; no drug tested

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2006-12-21
• Last updated: 2021-04-09

Locations

45 sites across 14 countries: Austria, Belgium, Croatia, Finland, France, Georgia, Germany, Ireland, Italy, Malta, Poland, Portugal, Spain, United Kingdom