NCT02544594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

September 2, 2015

Last Update Submit

October 10, 2019

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction (LVEF) on day 30

    30 days

Secondary Outcomes (8)

  • 30-day mortality

    30 days

  • Lactate levels

    up to 48 hours

  • potentia hydrogenic levels

    48 hours

  • Length of mechanical ventilation

    30 days

  • Long-term mortality at 12 months

    up to 12 months

  • +3 more secondary outcomes

Study Arms (2)

Extra-Corporal Life Support (ECLS)

ACTIVE COMPARATOR

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

Device: Extra-Corporal Life Support (ECLS)

Standard treatment

NO INTERVENTION

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

Interventions

Extra-Corporal Life Support (ECLS)DEVICE

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

Extra-Corporal Life Support (ECLS)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Munich

Munich, Bavaria, 81377, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31072581DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Stefan Brunner, MD

    Munich University Hospital

    PRINCIPAL INVESTIGATOR

  • Steffen Massberg, MD

    Munich University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 9, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Locations

DE(1)