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

June 13, 2012 updated by: Prof. Dr. Arndt Rolfs, University of Rostock

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Altenburg, Germany, 04600
        • Department of Neurology, Kreiskrankenhaus Altenburg
      • Berlin, Germany, 12351
        • Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln
      • Celle, Germany, 29223
        • Department of Neurology, Allgemeines Krankenhaus Celle
      • Chemnitz, Germany, 09131
        • Department of Neurology, Klinikum Chemnitz gGmbH
      • Duesseldorf, Germany, D-40225
        • Heinrich-Heine University Duesseldorf, Dept. of Neurology
      • Giessen, Germany, 35392
        • Universitätsklinikum Giessen, Department of Neurology
      • Hamburg, Germany, 20246
        • Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany, 69120
        • Universität Heidelberg, Klinik für Neurologie
      • Jena, Germany, 07740
        • Department of Neurology, Universitaetsklinikum Jena
      • Mühlhausen / Thürigen, Germany, 99974
        • Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg, Klinik für Neurologie
      • Rostock, Germany, D-18055
        • University of Rostock, Department of Neurology
      • Ulm, Germany, D-89081
        • University of Ulm, Department of Neurology
  • Poland
      • Warsaw, Poland, 02-957
        • Institute of Psychiatry and Neurology, Dept. of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with acute ischemic cerebrovascular event of any ischemic etiology

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Investigators

  • Principal Investigator: Arndt Rolfs, MD, University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 16, 2010

First Posted (Estimate)

August 17, 2010

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FD01/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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