• American heart journal · Apr 2021

    Randomized Controlled Trial Multicenter Study

    Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial.

    • Holger Thiele, Anne Freund, Gimenez Maria Rubini MR Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany., Suzanne de Waha-Thiele, Ibrahim Akin, Janine Pöss, Hans-Josef Feistritzer, Georg Fuernau, Tobias Graf, Holger Nef, Christian Hamm, Michael Böhm, Alexander Lauten, P Christian Schulze, Ingo Voigt, Peter Nordbeck, Stephan B Felix, Peter Abel, Stephan Baldus, Ulrich Laufs, Karsten Lenk, Ulf Landmesser, Carsten Skurk, Burkert Pieske, Carsten Tschöpe, Marcus Hennersdorf, Tobias Wengenmayer, Michael Preusch, Lars S Maier, Christian Jung, Malte Kelm, Peter Clemmensen, Dirk Westermann, Tim Seidler, Bernhard Schieffer, Tienush Rassaf, Amir-Abbas Mahabadi, Mariuca Vasa-Nicotera, Felix Meincke, Melchior Seyfarth, Alexander Kersten, Wolfgang Rottbauer, Peter Boekstegers, Ralf Muellenbach, Thomas Dengler, Christoph Kadel, Benjamin Schempf, Christian Karagiannidis, Hans-Bernd Hopf, Ralf Lehmann, Alexander Bufe, Stefan Baumanns, Alper Öner, Axel Linke, Daniel Sedding, Markus Ferrari, Leonhard Bruch, Britta Goldmann, Stefan John, Helge Möllmann, Jutta Franz, Harald Lapp, Philipp Lauten, Marko Noc, Tomaz Goslar, Ilka Oerlecke, Taoufik Ouarrak, Steffen Schneider, Steffen Desch, Uwe Zeymer, and ECLS-SHOCK Investigators.
    • Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany. Electronic address: holger.thiele@medizin.uni-leipzig.de.
    • Am. Heart J. 2021 Apr 1; 234: 1-11.

    BackgroundIn acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted.Study DesignThe ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke.ConclusionsThe ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.Copyright © 2021 Elsevier Inc. All rights reserved.

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