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

Cardiogenic Shock Clinical Trial

— ECLS-SHOCK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544594
• Other study ID #: GE IDE MucM001-15
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: March 2019

Study information

• Verified date: October 2019
• Source: Klinikum der Universitaet Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Extra-Corporal Life Support (ECLS)
Extra-Corporal Life Support (ECLS) (from Sorin)

Locations

Country	Name	City	State
Germany	University Hospital Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF) on day 30		30 days
Secondary	30-day mortality		30 days
Secondary	Lactate levels		up to 48 hours
Secondary	potentia hydrogenic levels		48 hours
Secondary	Length of mechanical ventilation		30 days
Secondary	Long-term mortality at 12 months		up to 12 months
Secondary	Length of ICU stay		30 days
Secondary	Neurological Outcome (modified Rankin Scale)		up to 12 months
Secondary	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