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

LMU Klinikum

Status and phase: Completed; Phase 4

Conditions: Cardiogenic Shock

Treatments: Device: Extra-Corporal Life Support (ECLS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02544594

GE IDE MucM001-15

Details and patient eligibility

About

This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Extra-Corporal Life Support (ECLS)

Active Comparator group

Description:

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

Treatment:

Device: Extra-Corporal Life Support (ECLS)

Standard treatment

No Intervention group

Description:

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