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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.

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
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Coordinator

UNIVERSITAET zu LUEBECK
Address
Ratzeburger Allee 160
23562 Lubeck
Germany

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Annette Bender (Mrs.)
EU contribution
€ 2 100 350

Participants (23)

STIFTUNG INSTITUT FUR HERZINFARKTFORSCHUNG LUDWIGSHAFEN
Germany
EU contribution
€ 1 060 000
Address
Bremserstrasse 79
67063 Ludwigshafen

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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

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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

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Activity type
Research Organisations
Administrative Contact
Andrea Prusse (Ms.)
VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINE SANTAROS KLINIKOS
Lithuania
EU contribution
€ 41 720
Address
Santariskiu G 2
LT-08661 Vilnius

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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
€ 25 000
Address
3 Avenue Victoria
75000 Paris

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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
€ 511 083
Address
Boulevard De L Hopital 47
75013 Paris

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Activity type
Research Organisations
Administrative Contact
Vanessa Gallois (Ms.)
UNIVERZITETNI KLINICNI CENTER LJUBLJANA
Slovenia
EU contribution
€ 72 000
Address
Zaloska Cesta 002
1000 Ljubljana

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Miha Zemlja (Mr.)
NARODOWY INSTYTUT KARDIOLOGII STEFANA KARDYNALA WYSZYNSKIEGO - PANSTWOWY INSTYTUT BADAWCZY
Poland
EU contribution
€ 34 600
Address
Ul. Alpejska 42
04 628 Warszawa

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Activity type
Research Organisations
Administrative Contact
Marek Banaszewski (Mr.)
INSELSPITAL-STIFTUNG
Switzerland
EU contribution
€ 17 046
Address
Freiburgstrasse 18
3010 Bern

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Activity type
Research Organisations
Administrative Contact
Stephan Windecker (Prof.)
UPPSALA UNIVERSITET

Participation ended

Sweden
Address
Von Kraemers Alle 4
751 05 Uppsala

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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

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Higher or Secondary Education Establishments
Administrative Contact
Joe Galloway (Mr.)
AZIENDA UNITA SANITARIA LOCALE DI REGGIO EMILIA
Italy
EU contribution
€ 10 000
Address
Via Amendola 2
42100 Reggio Emilia

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Teresa Coppola (Dr.)
ARCISPEDALE SANTA MARIA NUOVA AZIENDA OSPEDALIERA

Participation ended

Italy
Address
Viale Umberto I 50
42100 Reggio Emilia

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
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

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Fuchs (Mrs.)
UNIVERSITAET LEIPZIG
Germany
EU contribution
€ 631 603
Address
Ritterstrasse 26
04109 Leipzig

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Joachim Thiery (Prof.)
NATIONAL WAITING TIMES CENTRE BOARD
United Kingdom
EU contribution
€ 212 380
Address
Beardmore Street Clydebank
G81 4HX Glasgow

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Catherine Sinclair (Dr.)
HERZZENTRUM LEIPZIG GMBH
Germany
EU contribution
€ 277 100
Address
Struempellstrasse 39
04289 Leipzig

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Simone Bläser (Ms.)
AZIENDA OSPEDALIERA DELLA PROVINCIA DI LECCO

Participation ended

Italy
Address
Via Dell'eremo 9/11
23900 Lecco

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Micol Bernardi (Dr.)
AZIENDA SOCIO SANITARIA TERRITORIALE DI LECCO
Italy
EU contribution
€ 5 850
Address
Via Delleremo 9/11
23900 Lecco

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Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Anna Perego (Dr.)
UNIVERSITAIR ZIEKENHUIS ANTWERPEN
Belgium
EU contribution
€ 20 000
Address
Drie Eikenstraat 655
2650 Edegem

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Activity type
Research Organisations
Administrative Contact
Christiaan Vrints (Prof.)
ARTTIC
France
EU contribution
€ 195 645
Address
39 Rue Des Mathurins
75008 Paris

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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
€ 39 960
Address
Mariahilfer Strasse 49/19
1060 Wien

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Activity type
Research Organisations
Administrative Contact
Barbara Novak (Ms.)
INSEL GRUPPE AG
Switzerland
EU contribution
€ 8 000
Address
Freiburgstrasse 18
3010 Bern

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Stephan Windecker (Prof.)