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| Name | Class |
|---|---|
| Heart Center Leipzig - University Hospital | OTHER |
| IHF GmbH - Institut für Herzinfarktforschung | OTHER |
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The aim of the study is to examine whether treatment with extracorporeal life support (ECLS) in addition to revascularization with percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG) and optimal medical treatment is beneficial in comparison to no ECLS in patients with severe infarctrelated cardiogenic shock with respect to 30-day mortality
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECLS | Experimental | PCI (or CABG) plus medical treatment + ECLS |
|
| No ECLS | Active Comparator | PCI (or CABG) plus medical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECLS insertion | Procedure | After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned. ECLS insertion should be performed preferably before revascularization |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | 30-day all-cause death after randomization according to the intention-to-treat principle | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to death within 6 and 12 months follow-up | 6 and 12 months | |
| Length of mechanical ventilation | 0 to 10 days | |
| Time to hemodynamic stabilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele, MD | Director, Department of Cardiology, Heart Center Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Aachen | Aachen | 52074 | Germany | |||
| Zentralklinik Bad Berka GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114622 | Derived | Thevathasan T, Alyahoud M, Freund A, Akin I, Fichtlscherer S, Zeymer U, Feistritzer HJ, Poss J, Jobs A, Rossberg M, Jung C, Skurk C, Rassaf T, Ouarrak T, Schneider S, Thiele H, Desch S. Extracorporeal Membrane Oxygenation Complications Are Not Causal for Mortality in Patients With Infarct-Related Cardiogenic Shock: A Mediation Analysis of the Extracorporeal Life Support in Infarct-Related Cardiogenic Shock (ECLS-SHOCK) Trial. Crit Care Med. 2025 Dec 1;53(12):e2607-e2617. doi: 10.1097/CCM.0000000000006893. Epub 2025 Oct 17. | |
| 40139846 |
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| Revascularisation and optimal medical treatment | Other | After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned. |
|
| 0 to 10 days |
| Duration of catecholamine therapy | 0 to 10 days |
| Serial creatinine-level and creatinine-clearance | Creatinine-clearance (Cockcroft-Gault-Formula) | 0 to 10 days from time of randomization until stabilization |
| Length of ICU stay | 0 to 11 days |
| Length of hospital stay | 0 to 14 days |
| Serial SAPS-II score | 0 to 11 days |
| Mean and area under the curve of arterial lactate | 0 to 14 days |
| Acute renal failure requiring renal replacement therapy | 0 to 14 days |
| Cerebral performance category (CPC) | 30 days, 6 and 12 months |
| Cardiovascular mortality | 6 and 12 months |
| Hospitalization for heart failure | 6 and 12 months |
| Recurrent infarction | 30 days, 6 and 12 months |
| Repeat revascularization (PCI or CABG) | 30 days, 6 and 12 months |
| Status of Quality of life measured by EQ-5D-5L descriptive system | The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems expressed by 1-digit-numbers ranging from 1 (extreme problems) to 5 (no problems). The toal score ranges from 0-15 where 15 is the worst score. | 12 months |
| Status of Quality of life measured by EQ VAS | The EuroQol Group visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the maximum 100 is labelled 'The best health you can imagine' and the minimum 0 is labelled 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | 12 months |
| Bad Berka |
| 99438 |
| Germany |
| SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald | Bad Friedrichshall | 74177 | Germany |
| Kerckhoff-Klinik Forschungsgesellschaft mbH | Bad Nauheim | 61231 | Germany |
| Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie | Berlin | 12203 | Germany |
| BG Klinikum Unfallkrankenhaus Berlin gGmbH | Berlin | 12683 | Germany |
| Universitätsklinikum Köln Klinik III für Innere Medizin | Cologne | 50937 | Germany |
| St-Johannes-Hospital Klinik für Innere Medizin I | Dortmund | 44137 | Germany |
| Technische Universität Dresden | Dresden | 01062 | Germany |
| Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie | Düsseldorf | 40225 | Germany |
| Helios Klinikum Erfurt 3. Medizinische Klinik | Erfurt | 99089 | Germany |
| Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie | Essen | 45138 | Germany |
| Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen | Essen | 45147 | Germany |
| Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie | Frankfurt | 60590 | Germany |
| Klinikum Frankfurt Höchst | Frankfurt Höchst | 65929 | Germany |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Gießen | Giessen | 35392 | Germany |
| Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie | Göttingen | 37075 | Germany |
| Universitätsmedizin Greifswald | Greifswald | 17475 | Germany |
| Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III | Halle | 06120 | Germany |
| Asklepios Kliniken Hamburg GmbH | Hamburg | 20099 | Germany |
| Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie | Hamburg | 20246 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| SLK-Kliniken Heilbronn GmbH | Heilbronn | 74078 | Germany |
| Universitätsklinikum des Saarlandes Klinik für Innere Medizin III | Homburg | 66421 | Germany |
| Uniklinikum Jena Klinik für Innere Medizin I | Jena | 07747 | Germany |
| Klinikum Kassel GmbH | Kassel | 34125 | Germany |
| Helios Klinikum Krefeld | Krefeld | 47805 | Germany |
| Asklepios Kliniken Langen-Seligenstadt GmbH | Langen | 63225 | Germany |
| Universität Leipzig Klinik und Poliklinik für Kardiologie | Leipzig | 04103 | Germany |
| Herzzentrum Leipzig | Leipzig | Germany |
| Klinikum der Stadt Ludwigshafen gGmbH | Ludwigshafen | 67063 | Germany |
| Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin) | Lübeck | 23538 | Germany |
| Universitätsmedizin Mannheim | Mannheim | 68167 | Germany |
| Kliniken Mariahilf GmbH | Mönchengladbach | 41063 | Germany |
| Klinikum Nürnberg | Nuremberg | 90419 | Germany |
| Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II | Regensburg | 93053 | Germany |
| Kreiskliniken Reutlingen GmbH | Reutlingen | 72764 | Germany |
| Universitätsmedizin Rostock Zentrum für Innere Medizin | Rostock | 18057 | Germany |
| Helios Klinikum Siegburg | Siegburg | 53721 | Germany |
| Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie | Ulm | 89081 | Germany |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin | Wiesbaden | 65199 | Germany |
| Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie | Winnenden | 71364 | Germany |
| Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie | Wuppertal | 42117 | Germany |
| Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I | Würzburg | 97080 | Germany |
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| Derived |
| Feistritzer HJ, Zeymer U, Ouarrak T, Akin I, Rassaf T, Lehmann R, Eitel I, Seidler T, Skurk C, Clemmensen P, Voigt I, Seyfarth M, Linke A, Tigges E, Jung C, Lauten P, Poss J, Schneider S, Desch S, Freund A, Thiele H; ECLS-SHOCK Investigators. Different Mechanical Circulatory Support Strategies for Infarct-Related Cardiogenic Shock: A Subanalysis of the ECLS-SHOCK Trial. JACC Cardiovasc Interv. 2025 Mar 24;18(6):691-701. doi: 10.1016/j.jcin.2024.12.010. |
| 37634145 | Derived | Thiele H, Zeymer U, Akin I, Behnes M, Rassaf T, Mahabadi AA, Lehmann R, Eitel I, Graf T, Seidler T, Schuster A, Skurk C, Duerschmied D, Clemmensen P, Hennersdorf M, Fichtlscherer S, Voigt I, Seyfarth M, John S, Ewen S, Linke A, Tigges E, Nordbeck P, Bruch L, Jung C, Franz J, Lauten P, Goslar T, Feistritzer HJ, Poss J, Kirchhof E, Ouarrak T, Schneider S, Desch S, Freund A; ECLS-SHOCK Investigators. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock. N Engl J Med. 2023 Oct 5;389(14):1286-1297. doi: 10.1056/NEJMoa2307227. Epub 2023 Aug 26. |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
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