Extracorporeal Life Support in Cardiogenic Shock (ECLS-SHOCK)

Prospective Randomized Multicenter Study Comparing Extracorporeal Life Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Revascularization

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

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction; Cardiogenic Shock
• Intervention / Treatment: Procedure: ECLS insertion; Other: Revascularisation and optimal medical treatment

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen
  • Bad Berka, Germany, 99438
    • Zentralklinik Bad Berka GmbH
  • Bad Friedrichshall, Germany, 74177
    • SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik Forschungsgesellschaft mbH
  • Berlin, Germany, 12203
    • Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie
  • Berlin, Germany, 12683
    • BG Klinikum Unfallkrankenhaus Berlin gGmbH
  • Dortmund, Germany, 44137
    • St-Johannes-Hospital Klinik für Innere Medizin I
  • Dresden, Germany, 01062
    • Technische Universität Dresden
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie
  • Erfurt, Germany, 99089
    • Helios Klinikum Erfurt 3. Medizinische Klinik
  • Essen, Germany, 45138
    • Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie
  • Essen, Germany, 45147
    • Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie
  • Frankfurt Höchst, Germany, 65929
    • Klinikum Frankfurt Höchst
  • Freiburg, Germany, 79106
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin
  • Gießen, Germany, 35392
    • Universitätsklinikum Giessen
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie
  • Halle (Saale), Germany, 06120
    • Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III
  • Hamburg, Germany, 20099
    • Asklepios Kliniken Hamburg GmbH
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Heilbronn, Germany, 74078
    • SLK-Kliniken Heilbronn GmbH
  • Homburg, Germany, 66421
    • Universitätsklinikum des Saarlandes Klinik für Innere Medizin III
  • Jena, Germany, 07747
    • Uniklinikum Jena Klinik für Innere Medizin I
  • Kassel, Germany, 34125
    • Klinikum Kassel Gmbh
  • Krefeld, Germany, 47805
    • Helios Klinikum Krefeld
  • Köln, Germany, 50937
    • Universitätsklinikum Köln Klinik III für Innere Medizin
  • Langen, Germany, 63225
    • Asklepios Kliniken Langen-Seligenstadt GmbH
  • Leipzig, Germany
    • Herzzentrum Leipzig
  • Leipzig, Germany, 04103
    • Universität Leipzig Klinik und Poliklinik für Kardiologie
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen gGmbH
  • Lübeck, Germany, 23538
    • Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin)
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim
  • Mönchengladbach, Germany, 41063
    • Kliniken Mariahilf GmbH
  • Nürnberg, Germany, 90419
    • Klinikum Nürnberg
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II
  • Reutlingen, Germany, 72764
    • Kreiskliniken Reutlingen GmbH
  • Rostock, Germany, 18057
    • Universitätsmedizin Rostock Zentrum für Innere Medizin
  • Siegburg, Germany, 53721
    • Helios Klinikum Siegburg
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie
  • Wiesbaden, Germany, 65199
    • Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin
  • Winnenden, Germany, 71364
    • Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie
  • Wuppertal, Germany, 42117
    • Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I
• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECLS; PCI (or CABG) plus medical treatment + ECLS	Procedure: 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; Other: Revascularisation and optimal medical treatment; After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
Active Comparator: No ECLS; PCI (or CABG) plus medical treatment	Other: Revascularisation and optimal medical treatment; After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	30-day all-cause death after randomization according to the intention-to-treat principle	30 days

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Helios Health Institute GmbH
• Collaborators: Heart Center Leipzig - University Hospital; IHF GmbH - Institut für Herzinfarktforschung
• Investigators: Principal Investigator: Holger Thiele, MD, Director, Department of Cardiology, Heart Center Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): September 2, 2024

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Shock, Cardiogenic; Shock; Myocardial Infarction; Infarction
• Other Study ID Numbers: HRC[045584]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No