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

University of Rostock

Status: Completed

Conditions: Cerebrovascular Accident; Stroke, Acute; Cerebral Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01182818

FD01/2010

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

1,000 participants in 1 patient group

Observation

Description:

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