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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01182818

Acronym

FASEP

Enrollment

1000

Registered

2010-08-17

Start date

2010-09-30

Completion date

2012-04-30

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Stroke, Cerebrovascular Accident, Stroke, Acute

Keywords

Cerebrovascular Accident, Cerebrovascular Accident, Acute, Fabry Disease, Fabry´s Disease, Anderson-Fabry Disease, CVA (Cerebrovascular Accident), Stroke, Acute, Cerebral Stroke

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Countries

Germany, Poland

Outcome results