CORDIS
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CORDIS

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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.
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Coordinator

UNIVERSITAT ZU LUBECK

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)

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STIFTUNG INSTITUT FUR HERZINFARKTFORSCHUNG LUDWIGSHAFEN

Germany

EU Contribution

€ 837 720

ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM

Netherlands

EU Contribution

€ 384 720

VEREIN ZUR FOERDERUNG DER WISSENSCHAFTLICHEN FORSCHUNG AM WILHELMINENSPITAL DER STADT WIEN

Austria

VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINE SANTAROS KLINIKOS

Lithuania

EU Contribution

€ 75 720

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 195 900

A.C.T.I.O.N ALLIES IN CARDIOVASCULAR TRIALS INITIATIVES AND ORGANIZEDNETWORKS ASSOCIATION

France

EU Contribution

€ 599 580

UNIVERZITETNI KLINICNI CENTER LJUBLJANA

Slovenia

EU Contribution

€ 72 000

INSTYTUT KARDIOLOGII IM. PRYMASA TYSIACLECIA STEFANA KARDYNALA WYSZYNSKIEGO

Poland

EU Contribution

€ 138 600

INSELSPITAL-STIFTUNG

Switzerland

EU Contribution

€ 24 000

UPPSALA UNIVERSITET

Sweden

UNIVERSITY OF GLASGOW

United Kingdom

EU Contribution

€ 227 045

ARCISPEDALE SANTA MARIA NUOVA AZIENDA OSPEDALIERA

Italy

EU Contribution

€ 80 280

GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Germany

EU Contribution

€ 125 043

UNIVERSITAET LEIPZIG

Germany

EU Contribution

€ 512 439

NATIONAL WAITING TIMES CENTRE BOARD

United Kingdom

EU Contribution

€ 189 719

HERZZENTRUM LEIPZIG GMBH

Germany

EU Contribution

€ 212 100

AZIENDA OSPEDALIERA DELLA PROVINCIA DI LECCO

Italy

EU Contribution

€ 24 120

UNIVERSITAIR ZIEKENHUIS ANTWERPEN

Belgium

EU Contribution

€ 85 000

ARTTIC

France

EU Contribution

€ 165 647

VEREIN ZUR FORDERUNG DER FORSCHUNG AUF DEM GEBIET DER ARTERIOSKLEROSE THROMOBOSE UND VASKULAREN BIOLOGIE

Austria

EU Contribution

€ 45 960

Insel Gruppe AG

Switzerland

EU Contribution

€ 36 000

Project information

Grant agreement ID: 602202

Status

Closed project

  • Start date

    1 September 2013

  • End date

    31 August 2018

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 908 335,44

  • EU contribution

    € 5 999 145

Coordinated by:

UNIVERSITAT ZU LUBECK

Germany