European Registry on STEMI Patients Transferred for PCI With Upstream Use of Abciximab - EuroTransfer Registry

Acute Coronary Syndrome Clinical Trial

Official title:

European Registry on Patients With ST-Elevation MI Transferred for Mechanical Reperfusion (PCI)With a Special Focus on Upstream Use of Abciximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378391
• Other study ID #: H4S-PL-O067
• Status: Completed
• Phase: N/A
• First received: September 19, 2006
• Last updated: June 19, 2007
• Start date: November 2005
• Est. completion date: February 2007

Study information

• Verified date: June 2007
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

1. transferred from a surrounding regional community hospitals that the Cath Lab hospital has an established referral pattern with or

2. 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 Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• ST-Elevation Myocardial Infarction

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Germany	Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen
Italy	San Donato Hospital	Arezzo
Italy	Ospedale Carlo Poma	Mantova
Italy	Ospedale G.Pasquinucci	Massa
Italy	Santa Maria Nuova Hospital Reggio Emilia	Reggio Emilia
Italy	Ospedale S.Maria di Ca Foncello	Treviso
Poland	Cardiac Catheterization Laboratories Jagiellonian University Medical College, University Hospital	Krakow
Poland	Department of Interventional Cardiology, John Paul II Hospital	Krakow
Poland	Szpital Wojewodzki w Przemyslu	Przemysl
Poland	Szpital im. Szczeklika Tarnow	Tarnow
Slovenia	University Medical Center Ljubljana	Ljubljana
Spain	Hospital Juan Canalejo	Coruna
Spain	Hospital Clinico Universitario	Santiago de Compostela
Sweden	Linköping University Hospital	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Jagiellonian University	Foundation for Medical Research in Krakow, Poland

Countries where clinical trial is conducted

Finland,  Germany,  Italy,  Poland,  Slovenia,  Spain,  Sweden, 

External Links

•   registry homepage