Acute Myocardial InfarctionECLS-SHOCKNCT03637205
Extracorporeal Life Support in Cardiogenic Shock
A study testing ECLS insertion and Revascularisation and optimal medical treatment in people with Acute Myocardial Infarction and Cardiogenic Shock, run by Helios Health Institute GmbH at 46 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction, Cardiogenic Shock
- What is being tested?
- ECLS insertion and Revascularisation and optimal medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 20 Jun 2019to 2 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 9Show fewer
- Other severe concomitant disease with limited life expectancy <6 months
- Pregnancy
- Participation in another trial
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
Germany45 sites
Universitätsklinikum Aachen
Aachen, 52074
Zentralklinik Bad Berka GmbH
Bad Berka, 99438
SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald
Bad Friedrichshall, 74177
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, 61231
Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie
Berlin, 12203
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Berlin, 12683
Universitätsklinikum Köln Klinik III für Innere Medizin
Cologne, 50937
St-Johannes-Hospital Klinik für Innere Medizin I
Dortmund, 44137
Technische Universität Dresden
Dresden, 01062
Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, 40225
Helios Klinikum Erfurt 3. Medizinische Klinik
Erfurt, 99089
Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie
Essen, 45138
Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen
Essen, 45147
Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie
Frankfurt, 60590
Klinikum Frankfurt Höchst
Frankfurt Höchst, 65929
Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin
Freiburg im Breisgau, 79106
Universitätsklinikum Gießen
Giessen, 35392
Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie
Göttingen, 37075
Universitätsmedizin Greifswald
Greifswald, 17475
Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III
Halle, 06120
Asklepios Kliniken Hamburg GmbH
Hamburg, 20099
Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie
Hamburg, 20246
Universitätsklinikum Heidelberg
Heidelberg, 69120
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078
Universitätsklinikum des Saarlandes Klinik für Innere Medizin III
Homburg, 66421
Uniklinikum Jena Klinik für Innere Medizin I
Jena, 07747
Klinikum Kassel GmbH
Kassel, 34125
Helios Klinikum Krefeld
Krefeld, 47805
Asklepios Kliniken Langen-Seligenstadt GmbH
Langen, 63225
Universität Leipzig Klinik und Poliklinik für Kardiologie
Leipzig, 04103
Herzzentrum Leipzig
Leipzig
Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin)
Lübeck, 23538
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, 67063
Universitätsmedizin Mannheim
Mannheim, 68167
Kliniken Mariahilf GmbH
Mönchengladbach, 41063
Klinikum Nürnberg
Nuremberg, 90419
Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II
Regensburg, 93053
Kreiskliniken Reutlingen GmbH
Reutlingen, 72764
Universitätsmedizin Rostock Zentrum für Innere Medizin
Rostock, 18057
Helios Klinikum Siegburg
Siegburg, 53721
Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie
Ulm, 89081
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin
Wiesbaden, 65199
Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie
Winnenden, 71364
Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie
Wuppertal, 42117
Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I
Würzburg, 97080
About this study
Official title: 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
- Conditions
- Acute Myocardial Infarction, Cardiogenic Shock
- Being tested
- ECLS insertion, Revascularisation and optimal medical treatment
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECLS insertionProcedure or surgery
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 treatmentOther
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
| Study group | Role | What they receive |
|---|---|---|
| ECLS | Experimental | PCI (or CABG) plus medical treatment + ECLS Receives: Procedure: ECLS insertion; Other: Revascularisation and optimal medical treatment |
| No ECLS | Active comparator | PCI (or CABG) plus medical treatment Receives: Other: Revascularisation and optimal medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
30-day all-cause death after randomization according to the intention-to-treat principle
Measured: 30 days
Secondary outcomes (17)
Time to death within 6 and 12 months follow-up
Measured: 6 and 12 months
Length of mechanical ventilation
Measured: 0 to 10 days
Time to hemodynamic stabilization
Measured: 0 to 10 days
Duration of catecholamine therapy
Measured: 0 to 10 days
Serial creatinine-level and creatinine-clearance
Creatinine-clearance (Cockcroft-Gault-Formula)
Measured: 0 to 10 days from time of randomization until stabilization
Length of ICU stay
Measured: 0 to 11 days
Length of hospital stay
Measured: 0 to 14 days
Serial SAPS-II score
Measured: 0 to 11 days
Mean and area under the curve of arterial lactate
Measured: 0 to 14 days
Acute renal failure requiring renal replacement therapy
Measured: 0 to 14 days
Cerebral performance category (CPC)
Measured: 30 days, 6 and 12 months
Cardiovascular mortality
Measured: 6 and 12 months
Hospitalization for heart failure
Measured: 6 and 12 months
Recurrent infarction
Measured: 30 days, 6 and 12 months
Repeat revascularization (PCI or CABG)
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start20 Jun 2019
- Primary completion23 Dec 2022
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital, IHF GmbH - Institut für Herzinfarktforschung
- Responsible party
- Sponsor
- Investigators
- Holger Thiele, MD, Principal investigator, Director, Department of Cardiology, Heart Center Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637205
- Sponsor's protocol ID
- HRC[045584]
- Acronym
- ECLS-SHOCK
- Status last verified
- Dec 2024
- First submitted
- 13 Aug 2018
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41114622Feistritzer 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.
PubMed 40139846Thiele 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.
PubMed 37634145
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03637205
- Acronym / sponsor ID
- ECLS-SHOCK / HRC[045584]
- Conditions
- Acute Myocardial Infarction, Cardiogenic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital, IHF GmbH - Institut für Herzinfarktforschung
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECLS | Experimental | Procedure: ECLS insertion, Other: Revascularisation and optimal medical treatmentPCI (or CABG) plus medical treatment + ECLS |
| No ECLS | Active comparator | Other: Revascularisation and optimal medical treatmentPCI (or CABG) plus medical treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECLS insertionAfter 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 | Procedure or surgery | ECLS |
| Revascularisation and optimal medical treatmentAfter diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned. | Other | ECLS, No ECLS |
Primary outcome
30-day mortality
Time frame: 30 days
30-day all-cause death after randomization according to the intention-to-treat principle
17 secondary outcomes
Time to death within 6 and 12 months follow-up
Time frame: 6 and 12 months
Length of mechanical ventilation
Time frame: 0 to 10 days
Time to hemodynamic stabilization
Time frame: 0 to 10 days
Duration of catecholamine therapy
Time frame: 0 to 10 days
Serial creatinine-level and creatinine-clearance
Time frame: 0 to 10 days from time of randomization until stabilization
Length of ICU stay
Time frame: 0 to 11 days
Length of hospital stay
Time frame: 0 to 14 days
Serial SAPS-II score
Time frame: 0 to 11 days
Mean and area under the curve of arterial lactate
Time frame: 0 to 14 days
Acute renal failure requiring renal replacement therapy
Time frame: 0 to 14 days
Cerebral performance category (CPC)
Time frame: 30 days, 6 and 12 months
Cardiovascular mortality
Time frame: 6 and 12 months
Hospitalization for heart failure
Time frame: 6 and 12 months
Recurrent infarction
Time frame: 30 days, 6 and 12 months
Repeat revascularization (PCI or CABG)
Time frame: 30 days, 6 and 12 months
Status of Quality of life measured by EQ-5D-5L descriptive system
Time frame: 12 months
Status of Quality of life measured by EQ VAS
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 41114622Thevathasan 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.
- Derived from this study: PubMed 40139846Feistritzer 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.
- Derived from this study: PubMed 37634145Thiele 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Thiele, MD principal investigator
Director, Department of Cardiology, Heart Center Leipzig
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECLS insertion and Revascularisation and optimal medical treatment in people with Acute Myocardial Infarction and Cardiogenic Shock, run by Helios Health Institute GmbH at 46 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Germany, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03637205, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.