The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
MIX-ECMO
1 other identifier
observational
100
1 country
1
Brief Summary
Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 18, 2024
April 1, 2024
1 year
April 4, 2023
April 16, 2024
Conditions
Keywords
Outcome Measures
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
30 days
Secondary Outcomes (7)
All-cause mortality
30 days
Need for renal replacement therapy
30 days
Successful weaning from mechanical ventilation
30 days
Discharge from intensive care unit
30 days
Discharge from hospital
30 days
- +2 more secondary outcomes
Study Arms (1)
Investigation cohort
Cardiogenic shock patients from any cause receiving veno-arterial extracorporeal membrane oxygenation
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Semmelweis University Heart and Vascular Center
Budapest, BP, 1122, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 4, 2023
First Posted
May 3, 2023
Study Start
June 1, 2024
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
April 18, 2024
Record last verified: 2024-04