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Completed

NCT Number: NCT02544594

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Munich

Munich, Bavaria, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra-Corporal Life Support (ECLS)

Device

Extra-Corporal Life Support (ECLS) (from Sorin)

Primary outcomes

  1. Left ventricular ejection fraction (LVEF) on day 30

    Time frame: 30 days

Secondary outcomes

  1. 30-day mortality

    Time frame: 30 days

  2. Lactate levels

    Time frame: up to 48 hours

  3. potentia hydrogenic levels

    Time frame: 48 hours

  4. Length of mechanical ventilation

    Time frame: 30 days

  5. Long-term mortality at 12 months

    Time frame: up to 12 months

  6. Length of ICU stay

    Time frame: 30 days

  7. Neurological Outcome (modified Rankin Scale)

    Time frame: up to 12 months

  8. MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Official study title

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

Acronym: ECLS-SHOCK

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 9, 2015
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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