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| [ ...Back to search results ] | [ Print-friendly version ] |
| Frequency and characterisation of stroke rehabilitation in an unselected group of young stroke patients with Fabry disease |
| ISRCTN | ISRCTN26016503 |
| ClinicalTrials.gov identifier | NCT00414583 |
| Public title | Frequency and characterisation of stroke rehabilitation in an unselected group of young stroke patients with Fabry disease |
| Scientific title | Frequency and characterisation of stroke rehabilitation in an unselected group of young stroke patients with Fabry disease: a prevalence study |
| Acronym | SIFAP |
| Serial number at source | II PV 03/2006; II PV 04/2006 (NCT00413595) |
| Study hypothesis | To analyse the frequency of Fabry disease in an unselected group of cardiovascular event (CVE) patients aged between 18 and 55 years. |
| Lay summary | |
| Ethics approval | Germany: Ethics Committee of the Medical Association Mecklenburg-Vorpommern (Board 2), University of Rostock, gave approval on the 14th September 2006. All other centres will seek ethics approval before recruiting participants. |
| Study design | Observational, cohort, prevalence study |
| Countries of recruitment | Austria, Belgium, Croatia, Finland, France, Georgia, Germany, Ireland, Italy, Malta, Poland, Portugal, Spain, United Kingdom |
| Disease/condition/study domain | Fabry disease and stroke |
| Participants - inclusion criteria |
1. Adult patients (18 - 55 years of age, either sex) with an acute cerebrovascular event of any aetiology defined as patients having an acute ischaemic stroke or transient ischaemic attack less than 3 months before enrolment into the study
2. Magnetic resonance imaging (MRI)-scan evidence of associated corresponding brain infarction or haemorrhage, regardless of the duration of symptoms. Alternatively also patients with no signs of stroke in the MRI can be included if a stroke-experienced neurologist has done the initial diagnosis as ischaemic stroke, transient ischaemic attack or haemorrhage. 3. Detailed MRI documentation at admission to entry to the study 4. Diagnostic procedures for CVE according to the European Stroke Initiative (EUSI) recommendations 5. Written informed consent from patient or legal representative according to local regulations |
| Participants - exclusion criteria |
1. Patients being younger than 18 years or older than 55 years of age
2. Acute ischaemic stroke or transient ischaemic attack longer than 3 months before enrolment into the study 3. Diagnosis of the 3-month lasting CVE has been done by a non-neurologist if there is no MRI-scan evidence of associated brain infarction or haemorrhage 4. No detailed MRI documentation at admission to entry to the study |
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 5000 |
| Interventions |
Any participant who is eligible for entry to the study and has signed informed consent will have 20 ml of blood taken at baseline (V0). The following assessments will then be performed at the following timepoints:
1. Medical status (physical examination, clinical symptoms): V0 - V12 2. Enzyme replacement therapy/concomitant medication: V0 - V12 3. Adversene events/premature study termination: V1 - V12 4. Gb3 antibody levels: V0 - V12 5. Clinical chemistry: V0, V2, V4, V6, V8, V10, V12 6. Stroke classification: 6.1. Modified Rankin Scale (mRS): V0 6.2. TOAST criteria: V0 6.3. NIHSS: V0, V2, V4, V6, V8, V10, V12 6.4. Barthel Index: V0 7. Neuropsychological testing: 7.1. Mini-Mental State Examination (MMSE): V0 - V12 7.2. 36-item Short Form Health Survey (SF36): V0 - V12 7.3. Beck Depression Inventory II (BDI II): V0 - V12 7.4. Brief Pain Inventory (BPI): V0 - V12 8. Rostocker - Kopfschmerzfragen - Komplex (RoKoKo) (Austrian and German centres only) and Habi Test (Rostock centre only): V0, V2, V4, V6, V8, V10, V12 9. Electrocardiogram and echocardiography: V0, V4, B8, V12 10. Cardiac magnetic resonance imaging (MRI): V0, V12 11. Cerebral MRI: V0, V3, V6, V9, V12 12. Colour-coded duplex sonography/transcranial doppler sonography (TCD): V0, V2, V4, V6, V8, V10, V12 13. Renal sonography: V0, V2, V4, V6, V8, V10, V12 14. Opthalmological investigation: V0, V4, V8, V12 Timepoints are as follows: V0: Baseline V1: 4 months after baseline V2: 8 months after baseline V3: 12 months after baseline V4: 16 months after baseline V5: 20 months after baseline V6: 24 months after baseline V7: 28 months after baseline V8: 32 months after baseline V9: 36 months after baseline V10: 40 months after baseline V11: 44 months after baseline V12: 54 months after baseline (final visit) |
| Primary outcome measure(s) | Frequency of patients with Fabry disease in a cohort of acute stroke patients |
| Secondary outcome measure(s) |
The classification of stroke sub-type and degree of severity of stroke in patients identified to have Fabry disease according to:
1. TOAST (Trial of ORG 10172 in Acute Stroke Treatment) criteria (according to Adams, 1993) 2. Modified Rankin Scale for severity of stroke 3. Barthel Index 4. Magnetic Resonance Imaging (MRI) criteria |
| Sources of funding | Shire Human Genetic Therapies, Inc (USA) - unrestricted educational grant |
| Trial website | http://www.sifap.de/ |
| Publications | |
| Contact name | Prof Arndt Rolfs |
| Address |
Albrecht-Kossel-Institute for Neuroregeneration
University of Rostock Gehlsheimer Str. 20 |
| City/town | Rostock |
| Zip/Postcode | 18147 |
| Country | Germany |
| Tel | +49 (0)381 494 9514 |
| Fax | +49 (0)381 494 9542 |
| arndt.rolfs@med.uni-rostock.de | |
| Sponsor | Albrecht-Kossel-Institute for Neuroregeneration (Germany) |
| Address |
c/o Arndt Rolfs
University of Rostock Gehlsheimer Str. 20 |
| City/town | Rostock |
| Zip/Postcode | 18147 |
| Country | Germany |
| Tel | +49 (0)381 494 9514 |
| Fax | +49 (0)381 494 9542 |
| arndt.rolfs@med.uni-rostock.de | |
| Sponsor website: | http://albrecht-kossel-institut.de |
| Date applied | 13/01/2009 |
| Last edited | 27/02/2009 |
| Date ISRCTN assigned | 27/02/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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