The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients (MIX-ECMO)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication; Echocardiography; Myocardial Failure; Mechanical Circulatory Support

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Bálint K Lakatos, MD, PhD; Phone Number: +36306663540; Email: lakatos.balint@med.semmelweis-univ.hu

Study Locations

• Hungary
  • BP
    • Budapest, BP, Hungary, 1122
      • Semmelweis University Heart and Vascular Center
      • Contact: Bálint K Lakatos, MD, PhD; Phone Number: +36306663540; Email: lakatos.balint@med.semmelweis-univ.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Investigation cohort; Cardiogenic shock patients from any cause receiving veno-arterial extracorporeal membrane oxygenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death from any cause during the study period	30 days
Need for renal replacement therapy	The total number of patients who need for renal replacement therapy during intensive care	30 days
Successful weaning from mechanical ventilation	The total number of patients who can be successfully weaned from invasive mechanical ventilation	30 days
Discharge from intensive care unit	The total number of patients who are discharged from intensive care unit	30 days
Discharge from hospital	The total number of patients who are discharged from hospital	30 days
Ventilator-free days	Days spent without invasive mechanical ventilation	30 days
VA-ECMO-free days	Days spent without VA-ECMO support	30 days

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Collaborators: University Hospital, Limoges; I.Medizinische Klinik, Universitätsklinikum Mannheim

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Echocardiography; Cardiogenic shock; Myocardial work index; Extracorporeal Membrane Oxygenation Therapy
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Heart Failure; Shock, Cardiogenic
• Other Study ID Numbers: BMEÜ/4229- 1 /2022/EKU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No