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Multivessel versus culprit lesion only percutaneous revascularization in patients with acute myocardial infarction complicated by cardiogenic shock

Objective

Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) represents a major European health care concern with mortality rates between 40-70%. Approximately 70-80% of these patients present with multivessel disease defined as coronary lesions in more than one vessel. The clinician is faced with the decision to either 1) intervene only on the culprit lesion acutely responsible for the initiation of cardiogenic shock, or 2) treat additional lesions considered hemodynamically significant but not acutely triggering the CS cascade as well. Current guidelines recommend percutaneous coronary intervention of all critical lesions. However, due to a lack of randomized trials, these recommendations are solely based on registry data and pathophysiological considerations. Aim of the randomized CULPRIT-SHOCK trial is therefore to compare a) immediate multivessel PCI versus b) culprit lesion only PCI in patients with AMI complicated by CS. A total of 706 CS patients will be randomized in several European countries. The primary endpoint will be 30-day all-cause mortality and/or severe renal failure requiring renal replacement therapy. CULPRIT-SHOCK will therefore determine the optimal percutaneous revascularization strategy in patients with AMI and multivessel disease complicated by CS. In addition, a comprehensive array of efficacy, safety and socio-economic parameters for the chosen population will be assessed. Multiple secondary endpoints and several substudies (microcirculation, biomarkers, angiography) will serve to further understand the presumed differential effects of the 2 treatment arms and to understand the underlying pathophysiology and prognostic markers. From these parameters a multivariable regression model and a risk score for the prediction of clinical prognosis and a cost-effectiveness model in AMI and CS will be developed. Furthermore, CULPRIT-SHOCK will obtain data on CS patients not meeting inclusion criteria by instituting a separate registry.

Field of science

  • /medical and health sciences/basic medicine/physiology/pathophysiology
  • /social sciences/sociology/demography/mortality

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

UNIVERSITAET zu LUEBECK
Address
Ratzeburger Allee 160
23562 Lubeck
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 967 552
Administrative Contact
Annette Bender (Mrs.)

Participants (21)

STIFTUNG INSTITUT FUR HERZINFARKTFORSCHUNG LUDWIGSHAFEN
Germany
EU contribution
€ 837 720
Address
Bremserstrasse 79
67063 Ludwigshafen
Activity type
Research Organisations
Administrative Contact
Marco Dech (Mr.)
ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
EU contribution
€ 384 720
Address
Meibergdreef 15
1105AZ Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Edwin Groenewegen Van Wijk (Mr.)
VEREIN ZUR FOERDERUNG DER WISSENSCHAFTLICHEN FORSCHUNG AM WILHELMINENSPITAL DER STADT WIEN

Participation ended

Austria
Address
Montleartstrasse 37
1160 Wien
Activity type
Research Organisations
Administrative Contact
Andrea Prusse (Ms.)
VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINE SANTAROS KLINIKOS
Lithuania
EU contribution
€ 75 720
Address
Santariskiu G 2
08661 Vilnius
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Liuda Grigentiene (Ms.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 195 900
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
Administrative Contact
Alix Pillot (Ms.)
A.C.T.I.O.N ALLIES IN CARDIOVASCULAR TRIALS INITIATIVES AND ORGANIZEDNETWORKS ASSOCIATION
France
EU contribution
€ 599 580
Address
Boulevard De L Hopital 47
75013 Paris
Activity type
Research Organisations
Administrative Contact
Vanessa Gallois (Ms.)
UNIVERZITETNI KLINICNI CENTER LJUBLJANA
Slovenia
EU contribution
€ 72 000
Address
Zaloska Cesta 002
1000 Ljubljana
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Miha Zemlja (Mr.)
INSTYTUT KARDIOLOGII IM. PRYMASA TYSIACLECIA STEFANA KARDYNALA WYSZYNSKIEGO
Poland
EU contribution
€ 138 600
Address
Ul. Alpejska 42
04628 Warszawa
Activity type
Research Organisations
Administrative Contact
Marek Banaszewski (Mr.)
INSELSPITAL-STIFTUNG
Switzerland
EU contribution
€ 24 000
Address
Freiburgstrasse 18
3010 Bern
Activity type
Research Organisations
Administrative Contact
Stephan Windecker (Prof.)
UPPSALA UNIVERSITET

Participation ended

Sweden
Address
Von Kraemers Alle 4
751 05 Uppsala
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Johan Sundelin (Dr.)
UNIVERSITY OF GLASGOW
United Kingdom
EU contribution
€ 227 045
Address
University Avenue
G12 8QQ Glasgow
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Joe Galloway (Mr.)
ARCISPEDALE SANTA MARIA NUOVA AZIENDA OSPEDALIERA
Italy
EU contribution
€ 80 280
Address
Viale Umberto I 50
42100 Reggio Emilia
Activity type
Research Organisations
Administrative Contact
Teresa Coppola (Dr.)
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 125 043
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Fuchs (Mrs.)
UNIVERSITAET LEIPZIG
Germany
EU contribution
€ 512 439
Address
Ritterstrasse 26
04109 Leipzig
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Joachim Thiery (Prof.)
NATIONAL WAITING TIMES CENTRE BOARD
United Kingdom
EU contribution
€ 189 719
Address
Beardmore Street Clydebank
G81 4HX Glasgow
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Catherine Sinclair (Dr.)
HERZZENTRUM LEIPZIG GMBH
Germany
EU contribution
€ 212 100
Address
Struempellstrasse 39
04289 Leipzig
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Simone Bläser (Ms.)
AZIENDA OSPEDALIERA DELLA PROVINCIA DI LECCO
Italy
EU contribution
€ 24 120
Address
Via Dell'eremo 9/11
23900 Lecco
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Micol Bernardi (Dr.)
UNIVERSITAIR ZIEKENHUIS ANTWERPEN
Belgium
EU contribution
€ 85 000
Address
Wilrijkstraat 10
2650 Edegem
Activity type
Research Organisations
Administrative Contact
Christiaan Vrints (Prof.)
ARTTIC
France
EU contribution
€ 165 647
Address
Rue Du Dessous Des Berges 58A
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Martin Dietz (Dr.)
VEREIN ZUR FORDERUNG DER FORSCHUNG AUF DEM GEBIET DER ARTERIOSKLEROSE THROMOBOSE UND VASKULAREN BIOLOGIE
Austria
EU contribution
€ 45 960
Address
Mariahilfer Strasse 49/19
1060 Wien
Activity type
Research Organisations
Administrative Contact
Barbara Novak (Ms.)
Insel Gruppe AG
Switzerland
EU contribution
€ 36 000
Address
Freiburgstrasse 18
3010 Bern
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Stephan Windecker (Prof.)