Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/01/2009
Date assigned
27/02/2009
Last edited
15/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sifap.de/

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

http://albrecht-kossel-institut.de

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

  1. 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.

Additional files

Editorial Notes