Thiele, Holger and Freund, Anne and Gimenez, Maria Rubini and de Waha-Thiele, Suzanne and Akin, Ibrahim and Poss, Janine and Feistritzer, Hans-Josef and Fuernau, Georg and Graf, Tobias and Nef, Holger and Hamm, Christian and Bohm, Michael and Lauten, Alexander and Schulze, P. Christian and Voigt, Ingo and Nordbeck, Peter and Felix, Stephan B. and Abel, Peter and Baldus, Stephan and Laufs, Ulrich and Lenk, Karsten and Landmesser, Ulf and Skurk, Carsten and Pieske, Burkert and Tschope, Carsten and Hennersdorf, Marcus and Wengenmayer, Tobias and Preusch, Michael and Maier, Lars S. and Jung, Christian and Kelm, Malte and Clemmensen, Peter and Westermann, Dirk and Seidler, Tim and Schieffer, Bernhard and Rassaf, Tienush and Mahabadi, Amir-Abbas and Vasa-Nicotera, Mariuca and Meincke, Felix and Seyfarth, Melchior and Kersten, Alexander and Rottbauer, Wolfgang and Boekstegers, Peter and Muellenbach, Ralf and Dengler, Thomas and Kadel, Christoph and Schempf, Benjamin and Karagiannidis, Christian and Hopf, Hans-Bernd and Lehmann, Ralf and Bufe, Alexander and Baumanns, Stefan and Oner, Alper and Linke, Axel and Sedding, Daniel and Ferrari, Markus and Bruch, Leonhard and Goldmann, Britta and John, Stefan and Mollmann, Helge and Franz, Jutta and Lapp, Harald and Lauten, Philipp and Noc, Marko and Goslar, Tomaz and Oerlecke, Ilka and Ouarrak, Taoufik and Schneider, Steffen and 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. AMERICAN HEART JOURNAL, 234: 234. pp. 1-11. ISSN 0002-8703, 1097-6744
Full text not available from this repository. (Request a copy)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: | Article |
|---|---|
| Uncontrolled Keywords: | MEMBRANE-OXYGENATION; LEFT-VENTRICLE; MANAGEMENT; THERAPY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 04 Oct 2022 06:50 |
| Last Modified: | 04 Oct 2022 06:50 |
| URI: | https://pred.uni-regensburg.de/id/eprint/48177 |
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