Back to resultsExtracorporeal Life Support in Cardiogenic Shock (ECLS-SHOCK)
Primary Purpose
Acute Myocardial Infarction, Cardiogenic Shock
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ECLS insertion
Revascularisation and optimal medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility 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
Sites / Locations
- Herzzentrum Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ECLS
No ECLS
Arm Description
PCI (or CABG) plus medical treatment + ECLS
PCI (or CABG) plus medical treatment
Outcomes
Primary Outcome Measures
30-day mortality
30-day all-cause death after randomization according to the intention-to-treat principle
Secondary Outcome Measures
Time to death within 6 and 12 months follow-up
Length of mechanical ventilation
Time to hemodynamic stabilization
Duration of catecholamine therapy
Serial creatinine-level and creatinine-clearance
Creatinine-clearance (Cockcroft-Gault-Formula)
Length of ICU stay
Length of hospital stay
Serial SAPS-II score
Mean and area under the curve of arterial lactate
Acute renal failure requiring renal replacement therapy
Cerebral performance category (CPC)
Cardiovascular mortality
Hospitalization for heart failure
Recurrent infarction
Repeat revascularization (PCI or CABG)
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.
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.
Full Information
NCT ID
NCT03637205
First Posted
August 13, 2018
Last Updated
September 28, 2023
Sponsor
Helios Health Institute GmbH
Collaborators
Heart Center Leipzig - University Hospital, IHF GmbH - Institut für Herzinfarktforschung
1. Study Identification
Unique Protocol Identification Number
NCT03637205
Brief Title
Extracorporeal Life Support in Cardiogenic Shock
Acronym
ECLS-SHOCK
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
November 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helios Health Institute GmbH
Collaborators
Heart Center Leipzig - University Hospital, IHF GmbH - Institut für Herzinfarktforschung
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Cardiogenic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECLS
Arm Type
Experimental
Arm Description
PCI (or CABG) plus medical treatment + ECLS
Arm Title
No ECLS
Arm Type
Active Comparator
Arm Description
PCI (or CABG) plus medical treatment
Intervention Type
Procedure
Intervention Name(s)
ECLS insertion
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Revascularisation and optimal medical treatment
Intervention Description
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
Primary Outcome Measure Information:
Title
30-day mortality
Description
30-day all-cause death after randomization according to the intention-to-treat principle
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to death within 6 and 12 months follow-up
Time Frame
6 and 12 months
Title
Length of mechanical ventilation
Time Frame
0 to 10 days
Title
Time to hemodynamic stabilization
Time Frame
0 to 10 days
Title
Duration of catecholamine therapy
Time Frame
0 to 10 days
Title
Serial creatinine-level and creatinine-clearance
Description
Creatinine-clearance (Cockcroft-Gault-Formula)
Time Frame
0 to 10 days from time of randomization until stabilization
Title
Length of ICU stay
Time Frame
0 to 11 days
Title
Length of hospital stay
Time Frame
0 to 14 days
Title
Serial SAPS-II score
Time Frame
0 to 11 days
Title
Mean and area under the curve of arterial lactate
Time Frame
0 to 14 days
Title
Acute renal failure requiring renal replacement therapy
Time Frame
0 to 14 days
Title
Cerebral performance category (CPC)
Time Frame
30 days, 6 and 12 months
Title
Cardiovascular mortality
Time Frame
6 and 12 months
Title
Hospitalization for heart failure
Time Frame
6 and 12 months
Title
Recurrent infarction
Time Frame
30 days, 6 and 12 months
Title
Repeat revascularization (PCI or CABG)
Time Frame
30 days, 6 and 12 months
Title
Status of Quality of life measured by EQ-5D-5L descriptive system
Description
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.
Time Frame
12 months
Title
Status of Quality of life measured by EQ VAS
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD
Organizational Affiliation
Director, Department of Cardiology, Heart Center Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum Leipzig
City
Leipzig
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extracorporeal Life Support in Cardiogenic Shock
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