Extracorporeal Life Support in Cardiogenic Shock

NCT ID: NCT03637205

Last Updated: 2024-12-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2024-09-02

Brief Summary

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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

Detailed Description

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Conditions

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Acute Myocardial Infarction Cardiogenic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECLS

PCI (or CABG) plus medical treatment + ECLS

Group Type EXPERIMENTAL

ECLS insertion

Intervention Type 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

Revascularisation and optimal medical treatment

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Revascularisation and optimal medical treatment

Intervention Type OTHER

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

Intervention Type PROCEDURE

Revascularisation and optimal medical treatment

After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory:
* 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

* Resuscitation \>45 minutes
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Center Leipzig - University Hospital

OTHER

Sponsor Role collaborator

IHF GmbH - Institut für Herzinfarktforschung

OTHER

Sponsor Role collaborator

Helios Health Institute GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Site Status

SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald

Bad Friedrichshall, , Germany

Site Status

Kerckhoff-Klinik Forschungsgesellschaft mbH

Bad Nauheim, , Germany

Site Status

Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie

Berlin, , Germany

Site Status

BG Klinikum Unfallkrankenhaus Berlin gGmbH

Berlin, , Germany

Site Status

Universitätsklinikum Köln Klinik III für Innere Medizin

Cologne, , Germany

Site Status

St-Johannes-Hospital Klinik für Innere Medizin I

Dortmund, , Germany

Site Status

Technische Universität Dresden

Dresden, , Germany

Site Status

Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie

Düsseldorf, , Germany

Site Status

Helios Klinikum Erfurt 3. Medizinische Klinik

Erfurt, , Germany

Site Status

Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie

Essen, , Germany

Site Status

Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen

Essen, , Germany

Site Status

Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie

Frankfurt, , Germany

Site Status

Klinikum Frankfurt Höchst

Frankfurt Höchst, , Germany

Site Status

Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin

Freiburg im Breisgau, , Germany

Site Status

Universitätsklinikum Gießen

Giessen, , Germany

Site Status

Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie

Göttingen, , Germany

Site Status

Universitätsmedizin Greifswald

Greifswald, , Germany

Site Status

Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III

Halle, , Germany

Site Status

Asklepios Kliniken Hamburg GmbH

Hamburg, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie

Hamburg, , Germany

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

SLK-Kliniken Heilbronn GmbH

Heilbronn, , Germany

Site Status

Universitätsklinikum des Saarlandes Klinik für Innere Medizin III

Homburg, , Germany

Site Status

Uniklinikum Jena Klinik für Innere Medizin I

Jena, , Germany

Site Status

Klinikum Kassel GmbH

Kassel, , Germany

Site Status

Helios Klinikum Krefeld

Krefeld, , Germany

Site Status

Asklepios Kliniken Langen-Seligenstadt GmbH

Langen, , Germany

Site Status

Universität Leipzig Klinik und Poliklinik für Kardiologie

Leipzig, , Germany

Site Status

Herzzentrum Leipzig

Leipzig, , Germany

Site Status

Klinikum der Stadt Ludwigshafen gGmbH

Ludwigshafen, , Germany

Site Status

Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin)

Lübeck, , Germany

Site Status

Universitätsmedizin Mannheim

Mannheim, , Germany

Site Status

Kliniken Mariahilf GmbH

Mönchengladbach, , Germany

Site Status

Klinikum Nürnberg

Nuremberg, , Germany

Site Status

Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II

Regensburg, , Germany

Site Status

Kreiskliniken Reutlingen GmbH

Reutlingen, , Germany

Site Status

Universitätsmedizin Rostock Zentrum für Innere Medizin

Rostock, , Germany

Site Status

Helios Klinikum Siegburg

Siegburg, , Germany

Site Status

Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie

Ulm, , Germany

Site Status

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin

Wiesbaden, , Germany

Site Status

Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie

Winnenden, , Germany

Site Status

Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie

Wuppertal, , Germany

Site Status

Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I

Würzburg, , Germany

Site Status

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Germany Slovenia

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.

Reference Type DERIVED
PMID: 41114622 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40139846 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37634145 (View on PubMed)

Other Identifiers

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HRC[045584]

Identifier Type: -

Identifier Source: org_study_id