Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease

Completed

• Conditions: Stroke, Acute; Cerebrovascular Accident; Cerebral Stroke

• Registration Number: NCT01182818
• Lead Sponsor: University of Rostock

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 can only be explained for a minority 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 etiology can be an undiagnosed genetic disease, e.g. Fabry disease. Fabry disease is a lysosomal storage disorder known to cause vasculopathy. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry disease and what risk factors might be able to predict this disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Study Start: 2010-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Adult patients (18 - 60 years of age) with an acute ischemic cerebrovascular event either acute ischemic stroke or transient ischemic attack within 10 days
• Diagnosis of the cerebrovascular event (CVE) by a stroke experienced physician
• Diagnostic procedures for CVE according to the local guidelines and recommendations
• Written informed consent from patient or legal representative according to local regulations

Exclusion Criteria

• Patients being younger than 18 years or older than 60 years of age.
• Acute ischemic stroke or transient ischemic attack longer than 10 days before enrollment into the study
• CVE associated with intracranial hemorrhage as evidenced by cerebral CT scan
• Any uncertainty in the diagnosis
• No written informed consent from the patient or legal representative

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

Department of Neurology, Allgemeines Krankenhaus Celle; 🇩🇪 Celle, Germany

Universitätsklinikum Giessen, Department of Neurology; 🇩🇪 Giessen, Germany

Universität Heidelberg, Klinik für Neurologie; 🇩🇪 Heidelberg, Germany

Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln; 🇩🇪 Berlin, Germany

Heinrich-Heine University Duesseldorf, Dept. of Neurology; 🇩🇪 Duesseldorf, Germany

Department of Neurology, Kreiskrankenhaus Altenburg; 🇩🇪 Altenburg, Germany

Department of Neurology, Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Department of Neurology, Universitaetsklinikum Jena; 🇩🇪 Jena, Germany

University of Ulm, Department of Neurology; 🇩🇪 Ulm, Germany

Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH; 🇩🇪 Mühlhausen / Thürigen, Germany

Universitätsklinikum Regensburg, Klinik für Neurologie; 🇩🇪 Regensburg, Germany

University of Rostock, Department of Neurology; 🇩🇪 Rostock, Germany

Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Institute of Psychiatry and Neurology, Dept. of Neurology; 🇵🇱 Warsaw, Poland