Thiele, Holger ORCID: 0000-0002-0169-998X, Freund, Anne, Gimenez, Maria Rubini, de Waha-Thiele, Suzanne, Akin, Ibrahim, Poss, Janine, Feistritzer, Hans-Josef, Fuernau, Georg ORCID: 0000-0002-3813-8772, Graf, Tobias, Nef, Holger, Hamm, Christian, Bohm, Michael, Lauten, Alexander, Schulze, P. Christian, Voigt, Ingo, Nordbeck, Peter ORCID: 0000-0002-2560-4068, Felix, Stephan B., Abel, Peter, Baldus, Stephan, Laufs, Ulrich, Lenk, Karsten, Landmesser, Ulf, Skurk, Carsten, Pieske, Burkert, Tschope, Carsten ORCID: 0000-0001-5243-8985, Hennersdorf, Marcus, Wengenmayer, Tobias, Preusch, Michael, Maier, Lars S., Jung, Christian ORCID: 0000-0001-8325-250X, Kelm, Malte, Clemmensen, Peter, Westermann, Dirk, Seidler, Tim ORCID: 0000-0002-6158-5087, Schieffer, Bernhard, Rassaf, Tienush, Mahabadi, Amir-Abbas, Vasa-Nicotera, Mariuca, Meincke, Felix, Seyfarth, Melchior, Kersten, Alexander, Rottbauer, Wolfgang, Boekstegers, Peter, Muellenbach, Ralf, Dengler, Thomas, Kadel, Christoph, Schempf, Benjamin, Karagiannidis, Christian, Hopf, Hans-Bernd, Lehmann, Ralf, Bufe, Alexander, Baumanns, Stefan, Oner, Alper, Linke, Axel, Sedding, Daniel, Ferrari, Markus, Bruch, Leonhard, Goldmann, Britta, John, Stefan, Mollmann, Helge, Franz, Jutta, Lapp, Harald, Lauten, Philipp, Noc, Marko, Goslar, Tomaz, Oerlecke, Ilka, Ouarrak, Taoufik, Schneider, Steffen, Desch, Steffen and Zeymer, Uwe (2021). Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock-Design and rationale of the ECLS-SHOCK trial. Am. Heart J., 234. S. 1 - 12. NEW YORK: MOSBY-ELSEVIER. ISSN 1097-6744

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Thiele, HolgerUNSPECIFIEDorcid.org/0000-0002-0169-998XUNSPECIFIED
Freund, AnneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gimenez, Maria RubiniUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Waha-Thiele, SuzanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Akin, IbrahimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Poss, JanineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Feistritzer, Hans-JosefUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fuernau, GeorgUNSPECIFIEDorcid.org/0000-0002-3813-8772UNSPECIFIED
Graf, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nef, HolgerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hamm, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bohm, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lauten, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schulze, P. ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Voigt, IngoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nordbeck, PeterUNSPECIFIEDorcid.org/0000-0002-2560-4068UNSPECIFIED
Felix, Stephan B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Abel, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baldus, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Laufs, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lenk, KarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Landmesser, UlfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Skurk, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pieske, BurkertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tschope, CarstenUNSPECIFIEDorcid.org/0000-0001-5243-8985UNSPECIFIED
Hennersdorf, MarcusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wengenmayer, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Preusch, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maier, Lars S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jung, ChristianUNSPECIFIEDorcid.org/0000-0001-8325-250XUNSPECIFIED
Kelm, MalteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Clemmensen, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Westermann, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seidler, TimUNSPECIFIEDorcid.org/0000-0002-6158-5087UNSPECIFIED
Schieffer, BernhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rassaf, TienushUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mahabadi, Amir-AbbasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vasa-Nicotera, MariucaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meincke, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seyfarth, MelchiorUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kersten, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rottbauer, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boekstegers, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Muellenbach, RalfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dengler, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kadel, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schempf, BenjaminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Karagiannidis, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hopf, Hans-BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lehmann, RalfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bufe, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baumanns, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oner, AlperUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Linke, AxelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sedding, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ferrari, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruch, LeonhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goldmann, BrittaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
John, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mollmann, HelgeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Franz, JuttaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lapp, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lauten, PhilippUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Noc, MarkoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goslar, TomazUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oerlecke, IlkaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ouarrak, TaoufikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneider, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Desch, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zeymer, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-607813
DOI: 10.1016/j.ahj.2021.01.002
Journal or Publication Title: Am. Heart J.
Volume: 234
Page Range: S. 1 - 12
Date: 2021
Publisher: MOSBY-ELSEVIER
Place of Publication: NEW YORK
ISSN: 1097-6744
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
MEMBRANE-OXYGENATION; LEFT-VENTRICLE; MANAGEMENT; THERAPYMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60781

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