Clinical trial NCT01182818: Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
Official title: FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accident
Stroke, Acute
Cerebral Stroke
Keywords: Cerebrovascular Accident
Cerebrovascular Accident, Acute
Fabry Disease
Fabry´s Disease
Anderson-Fabry Disease
CVA (Cerebrovascular Accident)
Stroke, Acute
Cerebral Stroke
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with acute ischemic cerebrovascular event of any ischemic etiology

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Altenburg
country: Germany
facility: Department of Neurology, Kreiskrankenhaus Altenburg
city: Berlin
country: Germany
facility: Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln
city: Celle
country: Germany
facility: Department of Neurology, Allgemeines Krankenhaus Celle
city: Chemnitz
country: Germany
facility: Department of Neurology, Klinikum Chemnitz gGmbH
city: Duesseldorf
country: Germany
facility: Heinrich-Heine University Duesseldorf, Dept. of Neurology
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen, Department of Neurology
city: Hamburg
country: Germany
facility: Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universität Heidelberg, Klinik für Neurologie
city: Jena
country: Germany
facility: Department of Neurology, Universitaetsklinikum Jena
city: Mühlhausen / Thürigen
country: Germany
facility: Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg, Klinik für Neurologie
city: Rostock
country: Germany
facility: University of Rostock, Department of Neurology
city: Ulm
country: Germany
facility: University of Ulm, Department of Neurology
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology, Dept. of Neurology
Study officials:
affiliation: University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration
name: Arndt Rolfs, MD
role: PRINCIPAL_INVESTIGATOR
References: