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Extracorporeal Life Support in Cardiogenic Shock (ECLS-SHOCK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03637205
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
Heart Center Leipzig - University Hospital
IHF GmbH - Institut für Herzinfarktforschung
Information provided by (Responsible Party):
Leipzig Heart Institute GmbH

Study Description
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Brief 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 severe infarctrelated cardiogenic shock with respect to 30-day mortality

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Cardiogenic Shock Procedure: ECLS insertion Other: Revascularisation and optimal medical treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days ]
    30-day all-cause death after randomization according to the intention-to-treat principle


Secondary Outcome Measures :
  1. Time to death within 6 and 12 months follow-up [ Time Frame: 6 and 12 months ]
  2. Length of mechanical ventilation [ Time Frame: 0 to 10 days ]
  3. Time to hemodynamic stabilization [ Time Frame: 0 to 10 days ]
  4. Duration of catecholamine therapy [ Time Frame: 0 to 10 days ]
  5. Serial creatinine-level and creatinine-clearance [ Time Frame: 0 to 10 days from time of randomization until stabilization ]
    Creatinine-clearance (Cockcroft-Gault-Formula)

  6. Length of ICU stay [ Time Frame: 0 to 11 days ]
  7. Length of hospital stay [ Time Frame: 0 to 14 days ]
  8. Serial SAPS-II score [ Time Frame: 0 to 11 days ]
  9. Mean and area under the curve of arterial lactate [ Time Frame: 0 to 14 days ]
  10. Acute renal failure requiring renal replacement therapy [ Time Frame: 0 to 14 days ]
  11. Cerebral performance category (CPC) [ Time Frame: 30 days, 6 and 12 months ]
  12. Cardiovascular mortality [ Time Frame: 6 and 12 months ]
  13. Hospitalization for heart failure [ Time Frame: 6 and 12 months ]
  14. Recurrent infarction [ Time Frame: 30 days, 6 and 12 months ]
  15. Repeat revascularization (PCI or CABG) [ Time Frame: 30 days, 6 and 12 months ]
  16. 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.

  17. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637205


Contacts
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Contact: Holger Thiele, MD +49 341 865 1428 holger.thiele@medizin.uni-leipzig.de

Locations
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Germany
Herzzentrum Leipzig Recruiting
Leipzig, Germany
Contact: Holger Thiele, MD         
Sponsors and Collaborators
Leipzig Heart Institute GmbH
Heart Center Leipzig - University Hospital
IHF GmbH - Institut für Herzinfarktforschung
Investigators
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Principal Investigator: Holger Thiele, MD Director, Department of Cardiology, Heart Center Leipzig
More Information
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Responsible Party: Leipzig Heart Institute GmbH
ClinicalTrials.gov Identifier: NCT03637205    
Other Study ID Numbers: HRC[045584]
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases