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Cerebrovascular Accidentsifap1NCT00414583

Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in Young Stroke Patients

An observational study of Cerebrovascular Accident, run by CENTOGENE GmbH Rostock at 45 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these cannot be explained by the classical risk factors such as diabetes, overweight and high blood pressure. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Cerebrovascular Accident
How many people
5,000 participants
Where
45 sitesin 14 countries
Study dates
Jan 2008to Jan 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology defined as patients having an acute ischemic stroke or transient ischemic attack less than 3 months before enrollment into the study

Who may be able to join

  • Adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology defined as patients having an acute ischemic stroke or transient ischemic attack less than 3 months before enrollment into the study
  • MRI-scan evidence of associated corresponding brain infarction or hemorrhage, 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 ischemic stroke, transient ischemic attack or hemorrhage.
  • Detailed MRI documentation at admission to entry to the study
  • Diagnostic procedures for CVE according to the EUSI recommendations
  • Written informed consent from patient or legal representative according to local regulations

Who cannot join

  • Patients being younger than 18 years or older than 55 years of age.
  • Acute ischemic stroke or transient ischemic attack longer than 3 months before enrolment into the study
  • Diagnosis of the CVE within the last 3 months has been done by a non-neurologist if there is no MRI-scan evidence of associated brain infarction or hemorrhage
  • No detailed MRI documentation at admission to entry to the study

Trial locations and contacts

45 sites in 14 countries.

45 sites in 14 countries

Germany26 sites

  • Department of Neurology, Kreiskrankenhaus Altenburg

    Altenburg, 04600

  • Department of Neurology, Klinikum Hohe Warte

    Bayreuth, 95445

  • Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln

    Berlin, 12351

  • Charite Campus Benjamin Franklin, Dept. of Neurology

    Berlin, D-12200

  • Klinikum Bremen Mitte gGmbH, Neurologische Klinik

    Bremen, 28177

  • Department of Neurology, Allgemeines Krankenhaus Celle

    Celle, 29223

  • Department of Neurology, Klinikum Chemnitz gGmbH

    Chemnitz, 09131

  • Department of Neurology, Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

  • Heinrich-Heine University Duesseldorf, Dept. of Neurology

    Düsseldorf, D-40225

  • Dept. of Neurology, Johann-Wolfgang-Goethe-Universität

    Frankfurt, 60528

  • University of Giessen-Marburg Dept. of Neurology

    Giessen, D-35385

  • Department of Neurology, Ernst-Moritz-Arndt-University

    Greifswald, 17489

  • Dept. of Neurology, Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie

    Halle, 06120

  • Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • University of Heidelberg, Department of Neurology

    Heidelberg, D-69120

  • Department of Neurology, Universitaetsklinikum Jena

    Jena, 07740

  • University Schleswig-Holstein, Dept. of Neurology

    Kiel, D-24105

  • Department of Neurology, Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Department of Neurology, Universitaetsklinikum Giessen und Marburg GmbH

    Marburg, 35039

  • Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH

    Mühlhausen, 99974

  • Ludwig-Maximilians-University of Munich, Dept. of Neurology

    München, D-81377

  • University of Muenster, Dept. of Neurology

    Münster, D-48149

  • Department of Neurology, Klinik und Poliklinik fuer Neurologie

    Regensburg, 93053

  • University of Rostock, Department of Neurology

    Rostock, D-18055

  • Department of Neurology, University Tuebingen

    Tübingen, 72076

  • University of Ulm, Department of Neurology

    Ulm, D-89081

Other trials in Germany

Austria5 sites

  • Universitätsklinikum für Neurologie

    Graz, A-8036

  • Department of Neurology, Universitaetsklinik fuer Neurologie Innsbruck

    Innsbruck, 6020

  • Wagner-Jauregg Linz, Department of Neurology

    Linz, A-4020

  • Christian-Doppler-Klinik, Department für medizin. Studien

    Salzburg, 5020

  • Krankenhaus der Barmherzigen Brüder, Abteilung für Neurologie

    Vienna, 1020

Other trials in Austria

Belgium2 sites

  • Middelheim General Hospital, Dept. of Neurology/Memory Clinic

    Antwerp, 2020

  • UZ Gasthuisburg Hospital

    Leuven, 3000

Other trials in Belgium

United Kingdom2 sites

  • Stroke Prevention Research Unit, Dept. of Clinical Neurology, University of Glasgow, Southern General Hospital

    Glasgow, Scotland, G51 4TF

  • Stroke Prevention Research Unit, John Radcliffe Hospital

    Oxford, OX39DU

Other trials in United Kingdom

Croatia1 site

  • Department of Neurology, University Hospital Sestre Milosrdnice

    Zagreb, 10000

Other trials in Croatia

Finland1 site

  • Helsinki University Central Hospital, Department of Neurology

    Helsinki, 00290

Other trials in Finland

France1 site

  • Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires

    Lyon, F-69003

Other trials in France

Georgia1 site

  • Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university

    Tbilisi, 0179

Other trials in Georgia

Ireland1 site

  • The Adelaide and Meath Hospital, Department of Neurology

    Dublin, 24

Other trials in Ireland

Italy1 site

  • Dept. of Neurology, Ospoedale Maggiore Policlinico

    Milan, 20122

Other trials in Italy

Malta1 site

  • Neuromedical Ward, Mater Dei Hospital

    Msida

Other trials in Malta

Poland1 site

  • Institute of Psychiatry and Neurology, Dept. of Neurology

    Warsaw, 02-957

Other trials in Poland

Portugal1 site

  • Centro Hospitalar de Lisboa Central, Servico de Neurologia

    Lisbon, 1150-199

Other trials in Portugal

Spain1 site

  • Department of Neurology, Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

About this study

Official title: Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in an Unselected Group of Young Stroke Patients: an International, Multicentre Prevalence Study

More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these cannot be explained by the classical risk factors such as diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called Fabry disease. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry Disease.

Read the detailed description

Aim:

To determine the frequency of Fabry disease in an unselected group of young patients (18 - 55 years of age) with acute cerebrovascular event (CVE)

Fabry disease and stroke:

Rolfs and co-workers have shown a high frequency of Fabry disease in a cohort of patients with cryptogenic stroke (4 % [28/721]) aged between 18 and 55 years. This corresponds to about 1.2 % in the general population of young stroke patients. Therefore the authors stated that Fabry disease must be considered in all cases of unexplained stroke in young patients, especially in cases with the combination of infarction in the vertebrobasilar artery system and proteinuria.

Cryptogenic strokes are cerebrovascular lesions of unknown origin. Clinical and laboratory data show that Fabry disease is itself a risk factor for accelerated atherosclerosis and cardiac and renal disease, which can lead to emboli and hypertension. The pilot-phase started April 2007; the official study started January 2008.

Being tested
No intervention
Keywords
Cerebrovascular Accident, Cerebrovascular Accident, Acute, CVA (Cerebrovascular Accident), Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke, Fabry Disease, Anderson-Fabry Disease, Fabry's Disease
Medical subject headings
Stroke, Fabry Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    Also called only 1 observational group

    Observational study, only laboratory analysis and diagnostic interventions done; no drug tested

Study groups in NCT00414583
Study groupRoleWhat they receive
Observationall adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of Fabry disease in the unselected group of young stroke patients

    Measured: baseline

Secondary outcomes (1)

  1. Classification of stroke subtype in patients identified to have Fabry disease acc. to TOAST criteria, modified Rankin scale, Barthel index and MRI criteria.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2006 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00414583
Sponsor's protocol ID
II PV03/2006
Acronym
sifap1
Status last verified
Apr 2020
First submitted
19 Dec 2006
Last updated
9 Apr 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Rolfs A, Bottcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Lohr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. doi: 10.1016/S0140-6736(05)67635-0.

    PubMed 16298216

  • Rolfs A, Martus P, Heuschmann PU, Grittner U, Holzhausen M, Tatlisumak T, Bottcher T, Fazekas F, Enzinger C, Ropele S, Schmidt R, Riess O, Norrving B; sifap1 Investigators. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years. Cerebrovasc Dis. 2011;31(3):253-62. doi: 10.1159/000322153. Epub 2010 Dec 21.

    PubMed 21178350

  • Thijs V, Grittner U, Fazekas F, McCabe DJH, Giese AK, Kessler C, Martus P, Norrving B, Ringelstein EB, Schmidt R, Tanislav C, Putaala J, Tatlisumak T, von Sarnowski B, Rolfs A, Enzinger C; Stroke in Fabry (SIFAP1) Investigators. Dolichoectasia and Small Vessel Disease in Young Patients With Transient Ischemic Attack and Stroke. Stroke. 2017 Sep;48(9):2361-2367. doi: 10.1161/STROKEAHA.117.017406. Epub 2017 Jul 28.

    PubMed 28754833

  • Aigner A, Grittner U, Rolfs A, Norrving B, Siegerink B, Busch MA. Contribution of Established Stroke Risk Factors to the Burden of Stroke in Young Adults. Stroke. 2017 Jul;48(7):1744-1751. doi: 10.1161/STROKEAHA.117.016599. Epub 2017 Jun 15.

    PubMed 28619986

  • von Sarnowski B, Schminke U, Grittner U, Tanislav C, Bottcher T, Hennerici MG, Tatlisumak T, Putaala J, Kaps M, Fazekas F, Enzinger C, Rolfs A, Kessler C; sifap1 Investigators. Posterior versus Anterior Circulation Stroke in Young Adults: A Comparative Study of Stroke Aetiologies and Risk Factors in Stroke among Young Fabry Patients (sifap1). Cerebrovasc Dis. 2017;43(3-4):152-160. doi: 10.1159/000454840. Epub 2017 Jan 14.

    PubMed 28088807

  • Huber R, Grittner U, Weidemann F, Thijs V, Tanislav C, Enzinger C, Fazekas F, Wolf M, Hennerici MG, McCabe DJ, Putaala J, Tatlisumak T, Kessler C, von Sarnowski B, Martus P, Kolodny E, Norrving B, Rolfs A; Stroke in Young Fabry Patients (SIFAP) Investigators. Patent Foramen Ovale and Cryptogenic Strokes in the Stroke in Young Fabry Patients Study. Stroke. 2017 Jan;48(1):30-35. doi: 10.1161/STROKEAHA.116.013620. Epub 2016 Nov 29.

    PubMed 27899752

  • Tatlisumak T, Putaala J, Innila M, Enzinger C, Metso TM, Curtze S, von Sarnowski B, Amaral-Silva A, Jungehulsing GJ, Tanislav C, Thijs V, Rolfs A, Norrving B, Fazekas F, Suomalainen A, Kolodny EH. Frequency of MELAS main mutation in a phenotype-targeted young ischemic stroke patient population. J Neurol. 2016 Feb;263(2):257-262. doi: 10.1007/s00415-015-7969-z. Epub 2015 Nov 14.

    PubMed 26566914

  • Wolf ME, Grittner U, Bottcher T, Norrving B, Rolfs A, Hennerici MG; sifap1 TM investigators. Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study. Cerebrovasc Dis. 2015;40(3-4):129-35. doi: 10.1159/000434760. Epub 2015 Jul 25.

    PubMed 26227782

  • Thijs V, Grittner U, Dichgans M, Enzinger C, Fazekas F, Giese AK, Kessler C, Kolodny E, Kropp P, Martus P, Norrving B, Ringelstein EB, Rothwell PM, Schmidt R, Tanislav C, Tatlisumak T, von Sarnowski B, Rolfs A; Stroke in Fabry Investigators. Family History in Young Patients With Stroke. Stroke. 2015 Jul;46(7):1975-8. doi: 10.1161/STROKEAHA.115.009341. Epub 2015 Jun 2.

    PubMed 26038521

  • Fazekas F, Enzinger C, Schmidt R, Grittner U, Giese AK, Hennerici MG, Huber R, Jungehulsing GJ, Kaps M, Kessler C, Martus P, Putaala J, Ropele S, Tanislav C, Tatlisumak T, Thijs V, von Sarnowski B, Norrving B, Rolfs A; SIFAP 1 Investigators. Brain magnetic resonance imaging findings fail to suspect Fabry disease in young patients with an acute cerebrovascular event. Stroke. 2015 Jun;46(6):1548-53. doi: 10.1161/STROKEAHA.114.008548. Epub 2015 Apr 21.

    PubMed 25899239

  • Tanislav C, Kropp P, Grittner U, Holzhausen M, Fazekas F, Jungehulsing GJ, Tatlisumak T, von Sarnowski B, Putaala J, Huber R, Thijs V, Schmidt R, Kaps M, Enzinger C, Dichgans M, Norrving B, Rolfs A. Clinically relevant depressive symptoms in young stroke patients - results of the sifap1 study. Neuroepidemiology. 2015;44(1):30-8. doi: 10.1159/000371389. Epub 2015 Jan 31.

    PubMed 25659436

  • Kaps M, Grittner U, Jungehulsing G, Tatlisumak T, Kessler C, Schmidt R, Jukka P, Norrving B, Rolfs A, Tanislav C; sifap1 Investigators. Clinical signs in young patients with stroke related to FAST: results of the sifap1 study. BMJ Open. 2014 Nov 7;4(11):e005276. doi: 10.1136/bmjopen-2014-005276.

    PubMed 25380809

  • Tanislav C, Grittner U, Misselwitz B, Jungehuelsing GJ, Enzinger C, von Sarnowski B, Putaala J, Kaps M, Kropp P, Rolfs A, Tatlisumak T, Fazekas F, Kolodny E, Norrving B. Lessons from everyday stroke care for clinical research and vice versa: comparison of a comprehensive and a research population of young stroke patients. BMC Neurol. 2014 Mar 7;14:45. doi: 10.1186/1471-2377-14-45.

    PubMed 24607068

  • Fazekas F, Enzinger C, Schmidt R, Dichgans M, Gaertner B, Jungehulsing GJ, Hennerici MG, Heuschmann P, Holzhausen M, Kaps M, Kessler C, Martus P, Putaala J, Ropele S, Tanislav C, Tatlisumak T, Norrving B, Rolfs A; sifap1 Investigators. MRI in acute cerebral ischemia of the young: the Stroke in Young Fabry Patients (sifap1) Study. Neurology. 2013 Nov 26;81(22):1914-21. doi: 10.1212/01.wnl.0000436611.28210.ec. Epub 2013 Nov 1.

    PubMed 24186912

  • Kropp P, Holzhausen M, Kolodny E, Becker U, Dichgans M, Diez-Tejedor E, Enzinger C, Fazekas F, Fuentes B, Karpinska A, Meyer W, Tanislav C, Bottcher T, Rolfs A; Stroke in Young Fabry Patients (sifap) Investigators. Headache as a symptom at stroke onset in 4,431 young ischaemic stroke patients. Results from the "Stroke in Young Fabry Patients (SIFAP1) study". J Neural Transm (Vienna). 2013 Oct;120(10):1433-40. doi: 10.1007/s00702-013-1014-0. Epub 2013 Jun 9.

    PubMed 23748977

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebrovascular Accident, run by CENTOGENE GmbH Rostock at 45 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Germany, Austria, Belgium, United Kingdom, Croatia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Fabry disease in the unselected group of young stroke patients (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00414583, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.

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