Extracorporeal Life Support in Cardiogenic Shock

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03637205
• Other study ID #: HRC[045584]
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: November 23, 2023

Study information

• Verified date: September 2023
• Source: Helios Health Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 severe infarctrelated cardiogenic shock with respect to 30-day mortality

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: November 23, 2023
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiogenic Shock
• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

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.

Locations

Country	Name	City	State
Germany	Herzzentrum Leipzig	Leipzig

Sponsors (3)

Lead Sponsor	Collaborator
Helios Health Institute GmbH	Heart Center Leipzig - University Hospital, IHF GmbH - Institut für Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	30-day all-cause death after randomization according to the intention-to-treat principle	30 days
Secondary	Time to death within 6 and 12 months follow-up		6 and 12 months
Secondary	Length of mechanical ventilation		0 to 10 days
Secondary	Time to hemodynamic stabilization		0 to 10 days
Secondary	Duration of catecholamine therapy		0 to 10 days
Secondary	Serial creatinine-level and creatinine-clearance	Creatinine-clearance (Cockcroft-Gault-Formula)	0 to 10 days from time of randomization until stabilization
Secondary	Length of ICU stay		0 to 11 days
Secondary	Length of hospital stay		0 to 14 days
Secondary	Serial SAPS-II score		0 to 11 days
Secondary	Mean and area under the curve of arterial lactate		0 to 14 days
Secondary	Acute renal failure requiring renal replacement therapy		0 to 14 days
Secondary	Cerebral performance category (CPC)		30 days, 6 and 12 months
Secondary	Cardiovascular mortality		6 and 12 months
Secondary	Hospitalization for heart failure		6 and 12 months
Secondary	Recurrent infarction		30 days, 6 and 12 months
Secondary	Repeat revascularization (PCI or CABG)		30 days, 6 and 12 months
Secondary	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.	12 months
Secondary	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.	12 months