Clinical trial NCT02544594: Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Official title: Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiogenic Shock
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF) on day 30
timeFrame: 30 days
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30 days
measure: Lactate levels
timeFrame: up to 48 hours
measure: potentia hydrogenic levels
timeFrame: 48 hours
measure: Length of mechanical ventilation
timeFrame: 30 days
measure: Long-term mortality at 12 months
timeFrame: up to 12 months
measure: Length of ICU stay
timeFrame: 30 days
measure: Neurological Outcome (modified Rankin Scale)
timeFrame: up to 12 months
measure: MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital Munich
state: Bavaria
Study officials:
affiliation: Munich University Hospital
name: Stefan Brunner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Munich University Hospital
name: Steffen Massberg, MD
role: STUDY_CHAIR
References:
citation: Brunner S, Guenther SPW, Lackermair K, Peterss S, Orban M, Boulesteix AL, Michel S, Hausleiter J, Massberg S, Hagl C. Extracorporeal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2019 May 14;73(18):2355-2357. doi: 10.1016/j.jacc.2019.02.044. No abstract available.