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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01182818
Other study ID # FD01/2010
Secondary ID
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


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, 

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