ST-Elevation Myocardial InfarctionNCT00378391
European Registry on STEMI Patients Transferred for PCI With Upstream Use of Abciximab - EuroTransfer Registry
An observational study of ST-Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Jagiellonian University at 15 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction, Acute Coronary Syndrome
- How many people
- 1,800 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Nov 2005to Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
Italy5 sites
San Donato Hospital
Arezzo
Ospedale Carlo Poma
Mantua
Ospedale G.Pasquinucci
Massa
Santa Maria Nuova Hospital Reggio Emilia
Reggio Emilia
Ospedale S.Maria di Ca Foncello
Treviso
Poland4 sites
Cardiac Catheterization Laboratories Jagiellonian University Medical College, University Hospital
Krakow, 31-501
Department of Interventional Cardiology, John Paul II Hospital
Krakow
Szpital Wojewodzki w Przemyslu
Przemyśl
Szpital im. Szczeklika Tarnow
Tarnów
Spain2 sites
Hospital Juan Canalejo
A Coruña
Hospital Clinico Universitario
Santiago de Compostela
About this study
Official title: 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.
- Keywords
- ST-Elevation Myocardial Infarction, upstream abciximab, guideline adherence, hospital networking
- Medical subject headings
- ST Elevation Myocardial Infarction, Acute Coronary Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startNov 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Defined population
- Time perspective
- Other
- Enrolment
- 1,800 participants
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Medical Research in Krakow, Poland
- Investigators
- Dariusz Dudek, Assoc. Prof., Principal investigator, Cardiac Catheterization Laboratories, Jagiellonian University Medical CollegeZbigniew Siudak, MD, Study chair, Cardiac Catheterization Laboratories, Jagiellonian University Medical CollegeLukasz Partyka, MD, PhD, Study director, KCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378391
- Sponsor's protocol ID
- H4S-PL-O067
- Status last verified
- Jun 2007
- First submitted
- 19 Sep 2006
- Last updated
- 20 Jun 2007
- Results posted
- No
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.
PubMed 24155092Dziewierz 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.
PubMed 23065325Dziewierz 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.
PubMed 22658254Siudak 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.
PubMed 20453640Dudek 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.
PubMed 19033011
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry on Patients With ST-Elevation MI Transferred for Mechanical Reperfusion (PCI)With a Special Focus on Upstream Use of Abciximab
- ClinicalTrials.gov ID
- NCT00378391
- Acronym / sponsor ID
- H4S-PL-O067
- Keywords
- ST-Elevation Myocardial Infarction, upstream abciximab, guideline adherence, hospital networking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Foundation for Medical Research in Krakow, Poland
- Study start
- Nov 2005
- Study completion
- Feb 2007
- First posted
- 20 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All consecutive STEMI patients >=18years arriving to the Cath Lab hospital (invasive facility center) from transfer.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2007.
- Derived from this study: PubMed 24155092Dziewierz 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.
- Derived from this study: PubMed 23065325Dziewierz 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.
- Derived from this study: PubMed 22658254Dziewierz 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.
- Derived from this study: PubMed 20453640Siudak 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.
- Derived from this study: PubMed 19033011Dudek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dariusz Dudek, Assoc. Prof. principal investigator
Cardiac Catheterization Laboratories, Jagiellonian University Medical College
Zbigniew Siudak, MD study chair
Cardiac Catheterization Laboratories, Jagiellonian University Medical College
Lukasz Partyka, MD, PhD study director
KCRI
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Jagiellonian University at 15 sites in 7 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 9 inclusion and 2 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 20 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Poland, Spain, Finland, Germany and 2 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378391, which also lists 5 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 20 Jun 2007.