Holger Thiele1, Anne Freund2, Maria Rubini Gimenez2, Suzanne de Waha-Thiele3, Ibrahim Akin4, Janine Pöss2, Hans-Josef Feistritzer2, Georg Fuernau3, Tobias Graf3, Holger Nef5, Christian Hamm6, Michael Böhm7, Alexander Lauten8, P Christian Schulze9, Ingo Voigt10, Peter Nordbeck11, Stephan B Felix12, Peter Abel12, Stephan Baldus13, Ulrich Laufs14, Karsten Lenk14, Ulf Landmesser15, Carsten Skurk15, Burkert Pieske16, Carsten Tschöpe16, Marcus Hennersdorf17, Tobias Wengenmayer18, Michael Preusch19, Lars S Maier20, Christian Jung21, Malte Kelm21, Peter Clemmensen22, Dirk Westermann22, Tim Seidler23, Bernhard Schieffer24, Tienush Rassaf25, Amir-Abbas Mahabadi25, Mariuca Vasa-Nicotera26, Felix Meincke27, Melchior Seyfarth28, Alexander Kersten29, Wolfgang Rottbauer30, Peter Boekstegers31, Ralf Muellenbach32, Thomas Dengler33, Christoph Kadel34, Benjamin Schempf35, Christian Karagiannidis36, Hans-Bernd Hopf37, Ralf Lehmann37, Alexander Bufe38, Stefan Baumanns39, Alper Öner40, Axel Linke41, Daniel Sedding40, Markus Ferrari42, Leonhard Bruch43, Britta Goldmann44, Stefan John45, Helge Möllmann46, Jutta Franz47, Harald Lapp48, Philipp Lauten48, Marko Noc49, Tomaz Goslar49, Ilka Oerlecke50, Taoufik Ouarrak51, Steffen Schneider51, Steffen Desch2, Uwe Zeymer51. 1. Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany. Electronic address: holger.thiele@medizin.uni-leipzig.de. 2. Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany. 3. University Heart Center Luebeck, Luebeck, Germany. 4. University Clinic Mannheim, Mannheim, Germany. 5. University Clinic Giessen, Giessen, Germany. 6. University Clinic Giessen, Giessen, Germany; Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany. 7. University Clinic Homburg, Homburg, Germany. 8. Helios Clinic Erfurt, Erfurt, Germany. 9. University Hospital Jena, Jena, Germany. 10. Contilia Elisabeth-Krankenhaus, Essen, Germany, Essen, Germany. 11. University Clinic Würzburg, Würzburg, Germany. 12. Dept. of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany. 13. Heart Center Cologne, University Clinic Cologne, Cologne, Germany. 14. University Clinic Leipzig, Leipzig, Germany. 15. Charité, Campus Benjamin Franklin, Berlin, Germany. 16. Charité University Medicine, Campus Virchow Klinikum and German Heart Center and Berlin Brandenburger Center for Regenerative Therapies (BCRT) of the Berlin Institute of Health (BIH), Berlin, Germany. 17. SLK-Clinic Heilbronn, Heilbronn, Germany. 18. University Heart Center Freiburg - Bad Krozingen, Freiburg, Germany. 19. University Clinic Heidelberg, Heidelberg, Germany. 20. University Clinic Regensburg, Regensburg, Germany. 21. University Clinic Düsseldorf, Düsseldorf, Germany. 22. University Heart Center Hamburg, Hamburg, Germany. 23. Heart Center Göttingen, University Medicine Göttingen, Göttingen, Germany. 24. University Clinic Marburg, Marburg, Germany. 25. Dept. of Cardiology and Vascular Medicine, West German Heart- and Vascular Center, University Hospital Essen, Germany. 26. University Clinic Frankfurt, Frankfurt, Germany. 27. Asklepios Clinic St. Georg, Hamburg, Germany. 28. Heart Center Wuppertal; Witten-Herdecke University, Wuppertal, Germany. 29. University Clinic Aachen, Aachen, Germany. 30. University Clinic Ulm, Ulm Germany. 31. Helios Clinic Siegburg, Siegburg, Germany. 32. Klinikum Kassel, Kassel, Germany. 33. SLK Clinic Bad Friedrichshall, Bad Friedrichshall, Germany. 34. Clinic Frankfurt Höchst, Frankfurt, Germany. 35. Clinic Reutlingen, Reutlingen, Germany. 36. ARDS and ECMO Center Cologne-Merheim, Cologne, Germany. 37. Asklepios Clinic Langen, Langen, Germany. 38. Helios Clinic Krefeld, Krefeld, University Witten/Herdecke, Germany. 39. Kliniken Maria Hilf, Mönchengladbach, Germany. 40. University Clinic Halle, Halle, Germany. 41. Heart Center Dresden - Technical University Dresden, Dresden, Germany. 42. Helios Klinik HSK Wiesbaden, Wiesbaden, Germany. 43. Unfallkrankenhaus Berlin, Berlin, Germany. 44. Asklepios Clinic Hamburg-Harburg, Hamburg, Germany. 45. Paracelsius Private University, Clinic Nuremberg, Campus South, Nuremberg, Germany. 46. St. Johannes Hospital Dortmund, Dortmund, Germany. 47. Clinic Winnenden, Winnenden, Germany. 48. Zentralklinik Bad Berka, Bad Berka, Germany. 49. University Medical Center Ljubljana, Ljubljana, Slovenia. 50. Leipzig Heart Institute, Leipzig, Germany. 51. Institut für Herzinfarktforschung, Ludwigshafen, Germany.
Abstract
BACKGROUND: In 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 DESIGN: The 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. CONCLUSIONS: The 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.
RCT Entities:
BACKGROUND: In 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 DESIGN: The 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. CONCLUSIONS: The 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.
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