- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378391
European Registry on STEMI Patients Transferred for PCI With Upstream Use of Abciximab - EuroTransfer Registry
European Registry on Patients With ST-Elevation MI Transferred for Mechanical Reperfusion (PCI)With a Special Focus on Upstream Use of Abciximab
EUROTRANSFER Registry is a prospective, international, web-based European Registry on Patients with ST-Elevation MI Transferred for Mechanical Reperfusion (PCI) with a Special Focus on Upstream Use of Abciximab.
This registry is designed to collect data on approximately 1800 patients during a 12 month enrollment period in up to 20 interventional cardiology centres with hospital transfer networks from all over Europe.
Analysis of this registry should allow to monitor transfer timelines of patients arriving to the cath-lab from the regional hospital with or without upstream start of abciximab and scheduled for mechanical reperfusion (PCI) as well as to monitor regional differences across Europe in regard to the impact that time of various stages of the treatment chain may have on clinical outcomes.
Study Overview
Status
Study Type
Enrollment
Contacts and Locations
Study Locations
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Helsinki, Finland
- Helsinki University Central Hospital
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Villingen, Germany
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
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Arezzo, Italy
- San Donato Hospital
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Mantova, Italy
- Ospedale Carlo Poma
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Massa, Italy
- Ospedale G.Pasquinucci
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Reggio Emilia, Italy
- Santa Maria Nuova Hospital Reggio Emilia
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Treviso, Italy
- Ospedale S.Maria di Ca Foncello
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Krakow, Poland, 31-501
- Cardiac Catheterization Laboratories Jagiellonian University Medical College, University Hospital
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Krakow, Poland
- Department of Interventional Cardiology, John Paul II Hospital
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Przemysl, Poland
- Szpital Wojewódzki w Przemyślu
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Tarnow, Poland
- Szpital im. Szczeklika Tarnow
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Ljubljana, Slovenia
- University Medical Center Ljubljana
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Coruna, Spain
- Hospital Juan Canalejo
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Santiago de Compostela, Spain
- Hospital Clinico Universitario
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Linköping, Sweden
- Linkoping University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
PATIENTS:
All consecutive STEMI patients >=18years arriving to the Cath Lab hospital (invasive facility center) from transfer.
Transfer with respect to this registry is defined as patients that reach the Cath Lab hospital:
- transferred from a surrounding regional community hospitals that the Cath Lab hospital has an established referral pattern with or
after being picked-up by an ambulance which is equipped/staffed to provide specific medical therapy (like prehospital thrombolysis or upstream abciximab). Usually these have a physician or specifically trained nurse on board.
CENTRES:
- Provide 24 hour/7 days on duty PCI service.
- Has an established regional hospital referral network with >=8 patients/month arriving from transfer (as defined above).
- A rate of >=10% of these transfer patients who receive upstream abciximab before or during transfer to the Cath Lab hospital. Start of abciximab in the ER or CCU of the Cath Lab hospital will not be considered as upstream start of abciximab.
Exclusion Criteria:
- Patients who arrive to the Cath Lab from other pathways than those specified above (a. and b.), e.g. those who come by ambulances that do not provide specific medical therapy or arrive directly to the ER of the Cath Lab hospital by own feet/car will not be included in this registry.
- Patients from controlled clinical trials shall be included as long as their actual treatment is fully known. Thus, participants from randomized trials with blinded treatment cannot be included in this registry.
Study Plan
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Other
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dariusz Dudek, Assoc. Prof., Cardiac Catheterization Laboratories, Jagiellonian University Medical College
- Study Chair: Zbigniew Siudak, MD, Cardiac Catheterization Laboratories, Jagiellonian University Medical College
- Study Director: Lukasz Partyka, MD, PhD, KCRI
Publications and helpful links
General Publications
- Dziewierz A, Siudak Z, Rakowski T, Kleczynski P, Zasada W, Dubiel JS, Dudek D. Impact of direct stenting on outcome of patients with ST-elevation myocardial infarction transferred for primary percutaneous coronary intervention (from the EUROTRANSFER registry). Catheter Cardiovasc Interv. 2014 Nov 15;84(6):925-31. doi: 10.1002/ccd.25266. Epub 2014 Jul 29.
- Dziewierz A, Siudak Z, Rakowski T, Kleczynski P, Dubiel JS, Dudek D. Early administration of abciximab reduces mortality in female patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the EUROTRANSFER Registry). J Thromb Thrombolysis. 2013 Oct;36(3):240-6. doi: 10.1007/s11239-012-0826-3.
- Dziewierz A, Mielecki W, Siudak Z, Rakowski T, Janzon M, Birkemeyer R, Zasada W, Dubiel JS, Dudek D. Early abciximab administration before primary percutaneous coronary intervention improves clinical outcome in diabetic patients with ST-segment elevation myocardial infarction (EUROTRANSFER Registry). Atherosclerosis. 2012 Jul;223(1):212-8. doi: 10.1016/j.atherosclerosis.2012.04.018. Epub 2012 May 15.
- Siudak Z, Zawislak B, Dziewierz A, Rakowski T, Jakala J, Bartus S, Noworolnik B, Zasada W, Dubiel JS, Dudek D. Transradial approach in patients with ST-elevation myocardial infarction treated with abciximab results in fewer bleeding complications: data from EUROTRANSFER registry. Coron Artery Dis. 2010 Aug;21(5):292-7. doi: 10.1097/MCA.0b013e32833aa6d1.
- Dudek D, Siudak Z, Janzon M, Birkemeyer R, Aldama-Lopez G, Lettieri C, Janus B, Wisniewski A, Berti S, Olivari Z, Rakowski T, Partyka L, Goedicke J, Zmudka K; EUROTRANSFER Registry Investigators. European registry on patients with ST-elevation myocardial infarction transferred for mechanical reperfusion with a special focus on early administration of abciximab -- EUROTRANSFER Registry. Am Heart J. 2008 Dec;156(6):1147-54. doi: 10.1016/j.ahj.2008.08.004. Epub 2008 Oct 19.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H4S-PL-O067
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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