Frequency and characterisation of stroke rehabilitation in an unselected group of young stroke patients with Fabry disease

ISRCTN	ISRCTN26016503
DOI	https://doi.org/10.1186/ISRCTN26016503
ClinicalTrials.gov number	NCT00414583
Secondary identifying numbers	II PV 03/2006; II PV 04/2006 (NCT00413595)

Submission date: 13/01/2009
Registration date: 27/02/2009
Last edited: 15/01/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Arndt Rolfs
Scientific

Albrecht-Kossel-Institute for Neuroregeneration
University of Rostock
Gehlsheimer Str. 20
Rostock
18147
Germany

Phone	+49 (0)381 494 9514
Email	arndt.rolfs@med.uni-rostock.de

Study information

Study design	Observational, cohort, prevalence study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Frequency and characterisation of stroke rehabilitation in an unselected group of young stroke patients with Fabry disease: a prevalence study
Study acronym	SIFAP
Study objectives	To analyse the frequency of Fabry disease in an unselected group of cardiovascular event (CVE) patients aged between 18 and 55 years.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	Fabry disease and stroke
Intervention	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)
Intervention type	Other
Primary outcome measure	Frequency of patients with Fabry disease in a cohort of acute stroke patients
Secondary outcome measures	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
Overall study start date	01/04/2007
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	5000
Key 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
Key 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
Date of first enrolment	01/04/2007
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Austria
Belgium
Croatia
Finland
France
Georgia
Germany
Ireland
Italy
Malta
Poland
Portugal
Spain
United Kingdom

Study participating centre

Albrecht-Kossel-Institute for Neuroregeneration

Rostock
18147
Germany

Sponsor information

Albrecht-Kossel-Institute for Neuroregeneration (Germany)
Research organisation

c/o Arndt Rolfs
University of Rostock
Gehlsheimer Str. 20
Rostock
18147
Germany

Phone	+49 (0)381 494 9514
Email	arndt.rolfs@med.uni-rostock.de
Website	http://albrecht-kossel-institut.de
"ROR"	https://ror.org/03zdwsf69

Funders

Funder type

Industry

Shire Human Genetic Therapies, Inc (USA) - unrestricted educational grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2013		Yes	No