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

Stroke, Acute Clinical Trial

— FASEP  

Official title:

FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182818
• Other study ID #: FD01/2010
• Status: Completed
• Phase: N/A
• First received: August 16, 2010
• Last updated: June 13, 2012
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Stroke
• Cerebrovascular Accident
• Fabry Disease
• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
Germany	Department of Neurology, Kreiskrankenhaus Altenburg	Altenburg
Germany	Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln	Berlin
Germany	Department of Neurology, Allgemeines Krankenhaus Celle	Celle
Germany	Department of Neurology, Klinikum Chemnitz gGmbH	Chemnitz
Germany	Heinrich-Heine University Duesseldorf, Dept. of Neurology	Duesseldorf
Germany	Universitätsklinikum Giessen, Department of Neurology	Giessen
Germany	Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universität Heidelberg, Klinik für Neurologie	Heidelberg
Germany	Department of Neurology, Universitaetsklinikum Jena	Jena
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	University of Ulm, Department of Neurology	Ulm
Poland	Institute of Psychiatry and Neurology, Dept. of Neurology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Countries where clinical trial is conducted

Germany,  Poland,