Table 1.
Synopsis with methodological characteristics of the sifap1 study
| Study design | Observational prospective cross-sectional multicentre multinational (European) study |
|---|---|
|
Study objectives | |
| Primary objectives |
To determine the prevalence of Fabry disease in young stroke patients |
| Secondary objectives |
To describe patterns of stroke in young patients |
|
Inclusion criteria | |
| Age |
18–55 years |
| Time since event |
Less than 3 months before inclusion into the study |
| Diagnosis |
Acute CVE of any aetiology (ischemic stroke, TIA, intracranial haemorrhage) |
| Verification of diagnosis |
Verification of brain infarction or haemorrhage by MRI scan. In case of negative MRI diagnosis confirmed by stroke-experienced neurologist (more than 2 years of experience in stroke and at least 6 years of experience in general neurology) |
| Diagnostic information |
MRI documentation available Diagnostic procedures according to EUSI/ESO recommendations |
| Ethics |
Written informed consent from patient or legal representative according to local ethics committee regulations |
|
Inclusion period |
April 2007 till January 2010 |
|
Number of participating countries |
15 |
|
Number of centres |
47 |
|
Number of included patients |
5023 |
| Overall inclusion rate in the 7 best recruiting centres | 52.9% |