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CompletedNCT01182818FASEPUpdated Jun 14, 2012

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

An observational study in Cerebrovascular Accident, Stroke, Acute and Cerebral Stroke, sponsored by University of Rostock. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-06-14.

Sponsored by University of Rostock · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 1,000 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Rostock is the lead sponsor of 46 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with acute ischemic cerebrovascular event of any ischemic etiology

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observation

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

06

Study locations

14 sites
  • Department of Neurology, Kreiskrankenhaus Altenburg
    Altenburg, 04600, Germany
  • Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln
    Berlin, 12351, Germany
  • Department of Neurology, Allgemeines Krankenhaus Celle
    Celle, 29223, Germany
  • Department of Neurology, Klinikum Chemnitz gGmbH
    Chemnitz, 09131, Germany
  • Heinrich-Heine University Duesseldorf, Dept. of Neurology
    Duesseldorf, D-40225, Germany
  • Universitätsklinikum Giessen, Department of Neurology
    Giessen, 35392, Germany
  • Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf
    Hamburg, 20246, Germany
  • Universität Heidelberg, Klinik für Neurologie
    Heidelberg, 69120, Germany
  • Department of Neurology, Universitaetsklinikum Jena
    Jena, 07740, Germany
  • Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH
    Mühlhausen / Thürigen, 99974, Germany
  • Universitätsklinikum Regensburg, Klinik für Neurologie
    Regensburg, 93053, Germany
  • University of Rostock, Department of Neurology
    Rostock, D-18055, Germany
  • University of Ulm, Department of Neurology
    Ulm, D-89081, Germany
  • Institute of Psychiatry and Neurology, Dept. of Neurology
    Warsaw, 02-957, Poland
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01182818
Lead sponsor
University of Rostock
Responsible party
Prof. Dr. Arndt Rolfs (Prof. Dr. med., University of Rostock) — Principal investigator
First posted
Aug 17, 2010
Start date
Sep 2010
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Jun 14, 2012

Study contacts

Arndt Rolfs, MD
principal investigator · University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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