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

Phase 4

Completed

• Conditions: Cardiogenic Shock
• Interventions: Device: Extra-Corporal Life Support (ECLS)

• Registration Number: NCT02544594
• Lead Sponsor: LMU Klinikum

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.

Study Timeline

• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-09
• Study Start: 2015-11
• Primary Completion: 2018-03
• Study Completion: 2019-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (LVEF) on day 30	30 days

Secondary Outcome Measures

Name	Time	Method
30-day mortality	30 days
potentia hydrogenic levels	48 hours
Length of ICU stay	30 days
Long-term mortality at 12 months	up to 12 months
Neurological Outcome (modified Rankin Scale)	up to 12 months
MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)	up to 12 months
Lactate levels	up to 48 hours
Length of mechanical ventilation	30 days

Trial Locations

Locations (1)

University Hospital Munich; 🇩🇪 Munich, Bavaria, Germany