Extracorporeal Life Support in Cardiogenic Shock (ECLS-SHOCK)

December 12, 2024 updated by: Helios Health Institute GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Universitatsklinikum 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days
30-day all-cause death after randomization according to the intention-to-treat principle
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to death within 6 and 12 months follow-up
Time Frame: 6 and 12 months
6 and 12 months
Length of mechanical ventilation
Time Frame: 0 to 10 days
0 to 10 days
Time to hemodynamic stabilization
Time Frame: 0 to 10 days
0 to 10 days
Duration of catecholamine therapy
Time Frame: 0 to 10 days
0 to 10 days
Serial creatinine-level and creatinine-clearance
Time Frame: 0 to 10 days from time of randomization until stabilization
Creatinine-clearance (Cockcroft-Gault-Formula)
0 to 10 days from time of randomization until stabilization
Length of ICU stay
Time Frame: 0 to 11 days
0 to 11 days
Length of hospital stay
Time Frame: 0 to 14 days
0 to 14 days
Serial SAPS-II score
Time Frame: 0 to 11 days
0 to 11 days
Mean and area under the curve of arterial lactate
Time Frame: 0 to 14 days
0 to 14 days
Acute renal failure requiring renal replacement therapy
Time Frame: 0 to 14 days
0 to 14 days
Cerebral performance category (CPC)
Time Frame: 30 days, 6 and 12 months
30 days, 6 and 12 months
Cardiovascular mortality
Time Frame: 6 and 12 months
6 and 12 months
Hospitalization for heart failure
Time Frame: 6 and 12 months
6 and 12 months
Recurrent infarction
Time Frame: 30 days, 6 and 12 months
30 days, 6 and 12 months
Repeat revascularization (PCI or CABG)
Time Frame: 30 days, 6 and 12 months
30 days, 6 and 12 months
Status of Quality of life measured by EQ-5D-5L descriptive system
Time Frame: 12 months
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
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helios Health Institute GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart Center Leipzig - University Hospital
IHF GmbH - Institut für Herzinfarktforschung

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Holger Thiele, MD, Director, Department of Cardiology, Heart Center Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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