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
  Purpose

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.


Condition
Cerebrovascular Accident
Stroke, Acute
Cerebral Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Biospecimen Retention:   Samples With DNA

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.


Enrollment: 1000
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
all adult patients (18 - 60 years of age) with an acute cerebrovascular event of any etiology

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients with acute ischemic cerebrovascular event of any ischemic etiology

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182818

Locations
Germany
Department of Neurology, Kreiskrankenhaus Altenburg
Altenburg, Germany, 04600
Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln
Berlin, Germany, 12351
Department of Neurology, Allgemeines Krankenhaus Celle
Celle, Germany, 29223
Department of Neurology, Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09131
Heinrich-Heine University Duesseldorf, Dept. of Neurology
Duesseldorf, Germany, D-40225
Universitätsklinikum Giessen, Department of Neurology
Giessen, Germany, 35392
Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universität Heidelberg, Klinik für Neurologie
Heidelberg, Germany, 69120
Department of Neurology, Universitaetsklinikum Jena
Jena, Germany, 07740
Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH
Mühlhausen / Thürigen, Germany, 99974
Universitätsklinikum Regensburg, Klinik für Neurologie
Regensburg, Germany, 93053
University of Rostock, Department of Neurology
Rostock, Germany, D-18055
University of Ulm, Department of Neurology
Ulm, Germany, D-89081
Poland
Institute of Psychiatry and Neurology, Dept. of Neurology
Warsaw, Poland, 02-957
Sponsors and Collaborators
University of Rostock
Investigators
Principal Investigator: Arndt Rolfs, MD University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Arndt Rolfs, Prof. Dr. med., University of Rostock
ClinicalTrials.gov Identifier: NCT01182818     History of Changes
Other Study ID Numbers: FD01/2010
Study First Received: August 16, 2010
Last Updated: June 13, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Rostock:
Cerebrovascular Accident
Cerebrovascular Accident, Acute
Fabry Disease
Fabry´s Disease
Anderson-Fabry Disease
CVA (Cerebrovascular Accident)
Stroke, Acute
Cerebral Stroke

Additional relevant MeSH terms:
Fabry Disease
Cerebral Infarction
Stroke
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 26, 2014