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

NCT ID: NCT01182818

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-04-30

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.

Conditions

Cerebrovascular Accident; Stroke, Acute; Cerebral Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation

all adult patients (18 - 60 years of age) with an acute cerebrovascular event of any etiology

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Arndt Rolfs

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arndt Rolfs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration

Locations

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

Düsseldorf, , 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, , Germany

Institute of Psychiatry and Neurology, Dept. of Neurology

Warsaw, , Poland

Countries

Germany; Poland

Related Links

http://www.fasep.eu

study homepage

Other Identifiers

FD01/2010

Identifier Type: -

Identifier Source: org_study_id