EchocardiographyMIX-ECMONCT05838937
The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
An observational study of Echocardiography and Mechanical Circulatory Support, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Echocardiography, Mechanical Circulatory Support, Myocardial Failure
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jun 2024to 1 Dec 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University Heart and Vascular Center
Budapest, BP, 1122
Bálint K Lakatos, MD, PhD, +36306663540, lakatos.balint@med.semmelweis-univ.hu
About this study
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.
- Conditions
- Echocardiography, Mechanical Circulatory Support, Myocardial Failure, Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication
- Keywords
- Echocardiography, Myocardial work index, Cardiogenic shock, Extracorporeal Membrane Oxygenation Therapy
- Medical subject headings
- Heart Failure, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Investigation cohort | Cardiogenic shock patients from any cause receiving veno-arterial extracorporeal membrane oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (7)
All-cause mortality
Death from any cause during the study period
Measured: 30 days
Need for renal replacement therapy
The total number of patients who need for renal replacement therapy during intensive care
Measured: 30 days
Successful weaning from mechanical ventilation
The total number of patients who can be successfully weaned from invasive mechanical ventilation
Measured: 30 days
Discharge from intensive care unit
The total number of patients who are discharged from intensive care unit
Measured: 30 days
Discharge from hospital
The total number of patients who are discharged from hospital
Measured: 30 days
Ventilator-free days
Days spent without invasive mechanical ventilation
Measured: 30 days
VA-ECMO-free days
Days spent without VA-ECMO support
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- I.Medizinische Klinik, Universitätsklinikum Mannheim, University Hospital, Limoges
- Responsible party
- Principal investigator, Balint Karoly Lakatos, Semmelweis University Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838937
- Sponsor's protocol ID
- BMEÜ/4229- 1 /2022/EKU
- Acronym
- MIX-ECMO
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
- ClinicalTrials.gov ID
- NCT05838937
- Acronym / sponsor ID
- MIX-ECMO / BMEÜ/4229- 1 /2022/EKU
- Conditions
- Echocardiography, Mechanical Circulatory Support, Myocardial Failure, Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication
- Keywords
- Echocardiography, Myocardial work index, Cardiogenic shock, Extracorporeal Membrane Oxygenation Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- I.Medizinische Klinik, Universitätsklinikum Mannheim, University Hospital, Limoges
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigation cohort | – | –Cardiogenic shock patients from any cause receiving veno-arterial extracorporeal membrane oxygenation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation
Time frame: 30 days
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
7 secondary outcomes
All-cause mortality
Time frame: 30 days
Need for renal replacement therapy
Time frame: 30 days
Successful weaning from mechanical ventilation
Time frame: 30 days
Discharge from intensive care unit
Time frame: 30 days
Discharge from hospital
Time frame: 30 days
Ventilator-free days
Time frame: 30 days
VA-ECMO-free days
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography and Mechanical Circulatory Support, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bálint K Lakatos, MD, PhD (+36306663540, lakatos.balint@med.semmelweis-univ.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.