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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Arndt Rolfs, University of Rostock
ClinicalTrials.gov Identifier:
NCT01182818
First received: August 16, 2010
Last updated: June 13, 2012
Last verified: June 2012
History of Changes

August 16, 2010
June 13, 2012
September 2010
April 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01182818 on ClinicalTrials.gov Archive Site
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Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Fabry diagnostic will be done centrally: blood samples will be stored for analysis of a-galactosidase in blood, Gb3 as well as lyso-Gb3. In all cases direct analysis of the gene will be done, especially in females where due to the Lyonisation effect a-galactosidase activity might be normal in blood although the patient might suffer from Fabry disease.
Probability Sample

Adult patients with acute ischemic cerebrovascular event of any ischemic etiology
  • Cerebrovascular Accident
  • Stroke, Acute
  • Cerebral Stroke
Not Provided
Observation
all adult patients (18 - 60 years of age) with an acute cerebrovascular event of any etiology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Poland
 
NCT01182818
FD01/2010
Yes
Prof. Dr. Arndt Rolfs, University of Rostock
University of Rostock
Not Provided
Principal Investigator: Arndt Rolfs, MD University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration
University of Rostock
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP