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Not yet recruitingNCT05838937MIX-ECMOUpdated Apr 18, 2024

The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

An observational study in Echocardiography, Mechanical Circulatory Support and Myocardial Failure, sponsored by Semmelweis University Heart and Vascular Center. Not yet recruiting at 1 site in Hungary. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Semmelweis University Heart and Vascular Center · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.

Read the detailed description

The study aims to examine the prognostic role of non-invasive myocardial work in veno-arterial extracorporeal membrane oxygenation therapy patients. Subjects with cardiogenic shock regardless of etiology will be enrolled 48-72 hours after the initiation of mechanical circulatory support. It is hypothesized that non-invasive myocardial work may be an independent prognosticator of the outcome.

02

Conditions studied

  • Echocardiography
  • Mechanical Circulatory Support
  • Myocardial Failure
  • Cardiogenic Shock
  • Extracorporeal Membrane Oxygenation Complication

Keywords

  • Echocardiography
  • Myocardial work index
  • Cardiogenic shock
  • Extracorporeal Membrane Oxygenation Therapy
03

In context

Shock, Cardiogenic

277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 142 observational studies indexed under Shock, Cardiogenic.

Browse Shock, Cardiogenic studies →

Lead sponsor

Semmelweis University Heart and Vascular Center is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Altogether 100 cardiogenic shock patients receiving veno-arterial extracorporeal membrane oxygenation therapy will be enrolled regardless the etiology. Both peripherially and centrally cannulated patients are eligible. Considering that the two populations are typically quite different in terms of indication for the therapy (ACS- or decompensated chronic heart failure-associated CS vs. cardiac surgery population), a balanced enrollment of the two methods will be facilitated. All LV venting options are eligible for enrollment, however, if utilized, the mode of LV unloading (central left atrial vent, Impella, transaortic LV pigtail catheter etc.) will also be collected.

Inclusion criteria

  • 18 years or older age
  • Severe cardiogenic shock requiring the initiation of VA-ECMO therapy
  • Stabile hemodynamic state and oxigenation with VA-ECMO and vasoactive support
  • Informed written consent (due to the nature of the study, from a legally eligible relative of the patient)

Exclusion criteria

Exclusion Criteria:

  • Younger than 18 years of age
  • Unstable hemodynamic state or suboptimal oxigenation despite established VA-ECMO and vasoactive support
  • Severe neurological damage or confirmed brain death at the time of enrollment which squarely indicates therapy limitation and poor short-term outcome
  • Transesophageal echocardiography is contraindicated
  • Suboptimal echocardiographic window
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • Investigation cohort

    Cardiogenic shock patients from any cause receiving veno-arterial extracorporeal membrane oxygenation

06

What researchers measure

Primary outcomes

  1. Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation

    The total number of patients who die from cardiovascular cause, or require for transition to long-term mechanical circulatory support (LVAD/BiVAD), or heart transplantation

    Time frame: 30 days

Secondary outcomes

  1. All-cause mortality

    Death from any cause during the study period

    Time frame: 30 days

  2. Need for renal replacement therapy

    The total number of patients who need for renal replacement therapy during intensive care

    Time frame: 30 days

  3. Successful weaning from mechanical ventilation

    The total number of patients who can be successfully weaned from invasive mechanical ventilation

    Time frame: 30 days

  4. Discharge from intensive care unit

    The total number of patients who are discharged from intensive care unit

    Time frame: 30 days

  5. Discharge from hospital

    The total number of patients who are discharged from hospital

    Time frame: 30 days

  6. Ventilator-free days

    Days spent without invasive mechanical ventilation

    Time frame: 30 days

  7. VA-ECMO-free days

    Days spent without VA-ECMO support

    Time frame: 30 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05838937
Lead sponsor
Semmelweis University Heart and Vascular Center
Collaborators
I.Medizinische Klinik, Universitätsklinikum Mannheim, University Hospital, Limoges
Responsible party
Balint Karoly Lakatos (Assistant Professor, Semmelweis University Heart and Vascular Center) — Principal investigator
First posted
May 3, 2023
Start date
Jun 1, 2024 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Apr 18, 2024

Study contacts

Bálint K Lakatos, MD, PhD
Contact
lakatos.balint@med.semmelweis-univ.hu
+36306663540

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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