Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
420 participants
INTERVENTIONAL
2019-06-20
2024-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ECLS
PCI (or CABG) plus medical treatment + ECLS
ECLS insertion
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
Revascularisation and optimal medical treatment
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
No ECLS
PCI (or CABG) plus medical treatment
Revascularisation and optimal medical treatment
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
Interventions
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ECLS insertion
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
Revascularisation and optimal medical treatment
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
Eligibility Criteria
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Inclusion Criteria
* Planned revascularization (PCI or alternatively CABG)
* Systolic blood pressure \<90 mmHg \>30 min or catecholamines required to maintain pressure \>90 mmHg during Systole
* Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental Status, b) Cold, clammy skin and extremities, c) Oliguria with urine output \<30 ml/h
* Arterial lactate \>3 mmol/l
* Informed consent
Exclusion Criteria
* Mechanical cause of cardiogenic shock
* Onset of shock \>12 h
* Severe peripheral artery disease with impossibility to insert ECLS cannulae
* Age \<18 years or age \>75 years
* Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
* Other severe concomitant disease with limited life expectancy \<6 months
* Pregnancy
* Participation in another trial
18 Years
75 Years
ALL
No
Sponsors
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Heart Center Leipzig - University Hospital
OTHER
IHF GmbH - Institut für Herzinfarktforschung
OTHER
Helios Health Institute GmbH
OTHER
Responsible Party
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Principal Investigators
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Holger Thiele, MD
Role: PRINCIPAL_INVESTIGATOR
Director, Department of Cardiology, Heart Center Leipzig
Locations
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Universitätsklinikum Aachen
Aachen, , Germany
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald
Bad Friedrichshall, , Germany
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, , Germany
Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie
Berlin, , Germany
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Berlin, , Germany
Universitätsklinikum Köln Klinik III für Innere Medizin
Cologne, , Germany
St-Johannes-Hospital Klinik für Innere Medizin I
Dortmund, , Germany
Technische Universität Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, , Germany
Helios Klinikum Erfurt 3. Medizinische Klinik
Erfurt, , Germany
Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie
Essen, , Germany
Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen
Essen, , Germany
Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie
Frankfurt, , Germany
Klinikum Frankfurt Höchst
Frankfurt Höchst, , Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin
Freiburg im Breisgau, , Germany
Universitätsklinikum Gießen
Giessen, , Germany
Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie
Göttingen, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III
Halle, , Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, , Germany
Universitätsklinikum des Saarlandes Klinik für Innere Medizin III
Homburg, , Germany
Uniklinikum Jena Klinik für Innere Medizin I
Jena, , Germany
Klinikum Kassel GmbH
Kassel, , Germany
Helios Klinikum Krefeld
Krefeld, , Germany
Asklepios Kliniken Langen-Seligenstadt GmbH
Langen, , Germany
Universität Leipzig Klinik und Poliklinik für Kardiologie
Leipzig, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, , Germany
Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin)
Lübeck, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Kliniken Mariahilf GmbH
Mönchengladbach, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II
Regensburg, , Germany
Kreiskliniken Reutlingen GmbH
Reutlingen, , Germany
Universitätsmedizin Rostock Zentrum für Innere Medizin
Rostock, , Germany
Helios Klinikum Siegburg
Siegburg, , Germany
Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie
Ulm, , Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin
Wiesbaden, , Germany
Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie
Winnenden, , Germany
Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie
Wuppertal, , Germany
Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I
Würzburg, , Germany
University Medical Centre Ljubljana
Ljubljana, , Slovenia
Countries
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References
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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 Oct 17. doi: 10.1097/CCM.0000000000006893. Online ahead of print.
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.
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.
Other Identifiers
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HRC[045584]
Identifier Type: -
Identifier Source: org_study_id