Stroke in Young Fabry Patients (sifap2): Characterization of the Stroke Rehabilitation

CENTOGENE

Status: Completed

Conditions: Cerebrovascular Accident; Fabry Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00413595

II PV04/2006

Details and patient eligibility

About

New studies indicate that in about 1 - 2 percent of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called Fabry disease. In this case certain fat molecules are not digested and broken down by the body - but remain in the cells. These fat molecules build up to dangerous levels, which start to damage the body, because they accumulate e.g. in the walls of the blood vessels. This accumulation in the blood vessels of the whole body may cause life-threatening malfunctions in the brain, inducing a stroke.

The purpose of this study is to investigate the stroke rehabilitation of Fabry patients during different therapeutic standard approaches for stroke and for Fabry disease (if any). During this study, stroke patients with Fabry disease will be monitored in greater detail to determine whether the differences in treatment are significant for patient recovery and on what they depend.

Full description

In a group of young stroke patients with diagnosed Fabry disease the stroke rehabilitation will be investigated during different prophylactic therapeutic approaches. In this study the investigator will not be given any instructions on stroke and Fabry therapy.

All patients with any etiology of stroke and a diagnosed Fabry disease submitted to the stroke unit of the participating centres which commit to work with the EUSI (European Stroke Initiative) recommendations for stroke management and diagnosis will be included into the study.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (18 - 55 years of age) with an acute cerebrovascular event (CVE) of any etiology defined as patients having an ischemic stroke or transient ischemic attack
• Genetic diagnosis (a-galactosidase defect)of Fabry disease
• Written informed consent from patient

Exclusion criteria

• No proven Fabry disease
• Participating in an other clinical trial with any investigational new drug or medical device
• Contraindication to any of the diagnostic procedures like e.g. MRI investigation
• Patient has been pretreated with Enzyme Replacement Therapy at the date of informed consent of sifap2

Trial design

100 participants in 1 patient group

Observation

Description:

Adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology and the genetic diagnosis (a-galactosidase defect) of Fabry disease

Treatment:

Other: No intervention