Contact information
Type
Scientific
Primary contact
Prof Arndt Rolfs
ORCID ID
Contact details
Albrecht-Kossel-Institute for Neuroregeneration
University of Rostock
Gehlsheimer Str. 20
Rostock
18147
Germany
+49 (0)381 494 9514
arndt.rolfs@med.uni-rostock.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00414583
Protocol/serial number
II PV 03/2006; II PV 04/2006 (NCT00413595)
Study information
Scientific title
Frequency and characterisation of stroke rehabilitation in an unselected group of young stroke patients with Fabry disease: a prevalence study
Acronym
SIFAP
Study hypothesis
To analyse the frequency of Fabry disease in an unselected group of cardiovascular event (CVE) patients aged between 18 and 55 years.
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
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/04/2007
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5000
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Austria, Belgium, Croatia, Finland, France, Georgia, Germany, Ireland, Italy, Malta, Poland, Portugal, Spain, United Kingdom
Trial participating centre
Albrecht-Kossel-Institute for Neuroregeneration
Rostock
18147
Germany
Sponsor information
Organisation
Albrecht-Kossel-Institute for Neuroregeneration (Germany)
Sponsor details
c/o Arndt Rolfs
University of Rostock
Gehlsheimer Str. 20
Rostock
18147
Germany
+49 (0)381 494 9514
arndt.rolfs@med.uni-rostock.de
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Shire Human Genetic Therapies, Inc (USA) - unrestricted educational grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in www.ncbi.nlm.nih.gov/pubmed/23306324
Publication citations
-
Results
Rolfs A, Fazekas F, Grittner U, Dichgans M, Martus P, Holzhausen M, Böttcher T, Heuschmann PU, Tatlisumak T, Tanislav C, Jungehulsing GJ, Giese AK, Putaala J, Huber R, Bodechtel U, Lichy C, Enzinger C, Schmidt R, Hennerici MG, Kaps M, Kessler C, Lackner K, Paschke E, Meyer W, Mascher H, Riess O, Kolodny E, Norrving B, , Acute cerebrovascular disease in the young: the Stroke in Young Fabry Patients study., Stroke, 2013, 44, 2, 340-349, doi: 10.1161/STROKEAHA.112.663708.