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Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction (ECLS-SHOCK)

Primary Purpose

Cardiogenic Shock

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Extra-Corporal Life Support (ECLS)
Sponsored by
LMU Klinikum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with

  • intended revascularization (PCI or CABG)
  • Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
  • Signs of left heart insufficiency and pulmonary congestion

  • Signs of impaired organ perfusion with at least one of the following:

    • Altered mental status
    • Cold, clammy skin
    • Urine output <30 ml/h
    • Serum lactate >2mmol/l
  • Informed consent

Exclusion Criteria:

  • Resuscitation > 60 minutes, ischemia > 10 minutes
  • No intrinsic heart action
  • Cerebral deficit with fixed dilated pupils
  • Mechanical infarction complication
  • Onset of shock > 12 h
  • Severe peripheral artery disease
  • Aortic regurgitation > II.°
  • Age > 80 years
  • shock of other cause
  • Other severe concomitant disease
  • participation in another trial

Sites / Locations

  • University Hospital Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Extra-Corporal Life Support (ECLS)

Standard treatment

Arm Description

Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction.

Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction.

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction (LVEF) on day 30

Secondary Outcome Measures

30-day mortality
Lactate levels
potentia hydrogenic levels
Length of mechanical ventilation
Long-term mortality at 12 months
Length of ICU stay
Neurological Outcome (modified Rankin Scale)
MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)

Full Information

First Posted
September 2, 2015
Last Updated
October 10, 2019
Sponsor
LMU Klinikum
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1. Study Identification

Unique Protocol Identification Number
NCT02544594
Brief Title
Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Acronym
ECLS-SHOCK
Official Title
Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
Detailed Description
Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function. This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction. The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extra-Corporal Life Support (ECLS)
Arm Type
Active Comparator
Arm Description
Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction.
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction.
Intervention Type
Device
Intervention Name(s)
Extra-Corporal Life Support (ECLS)
Intervention Description
Extra-Corporal Life Support (ECLS) (from Sorin)
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF) on day 30
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30-day mortality
Time Frame
30 days
Title
Lactate levels
Time Frame
up to 48 hours
Title
potentia hydrogenic levels
Time Frame
48 hours
Title
Length of mechanical ventilation
Time Frame
30 days
Title
Long-term mortality at 12 months
Time Frame
up to 12 months
Title
Length of ICU stay
Time Frame
30 days
Title
Neurological Outcome (modified Rankin Scale)
Time Frame
up to 12 months
Title
MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with intended revascularization (PCI or CABG) Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole Signs of left heart insufficiency and pulmonary congestion Signs of impaired organ perfusion with at least one of the following: Altered mental status Cold, clammy skin Urine output <30 ml/h Serum lactate >2mmol/l Informed consent Exclusion Criteria: Resuscitation > 60 minutes, ischemia > 10 minutes No intrinsic heart action Cerebral deficit with fixed dilated pupils Mechanical infarction complication Onset of shock > 12 h Severe peripheral artery disease Aortic regurgitation > II.° Age > 80 years shock of other cause Other severe concomitant disease participation in another trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Brunner, MD
Organizational Affiliation
Munich University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steffen Massberg, MD
Organizational Affiliation
Munich University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31072581
Citation
Brunner S, Guenther SPW, Lackermair K, Peterss S, Orban M, Boulesteix AL, Michel S, Hausleiter J, Massberg S, Hagl C. Extracorporeal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2019 May 14;73(18):2355-2357. doi: 10.1016/j.jacc.2019.02.044. No abstract available.
Results Reference
derived

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Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction

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