The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

NCT ID: NCT05838937

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Investigation cohort

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.Medizinische Klinik, Universitätsklinikum Mannheim

UNKNOWN

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role collaborator

Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role lead

Responsible Party

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Balint Karoly Lakatos

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Semmelweis University Heart and Vascular Center

Budapest, BP, Hungary

Site Status

Countries

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Hungary

Central Contacts

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Bálint K Lakatos, MD, PhD

Role: CONTACT

+36306663540

Facility Contacts

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Bálint K Lakatos, MD, PhD

Role: primary

+36306663540

Other Identifiers

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BMEÜ/4229- 1 /2022/EKU

Identifier Type: -

Identifier Source: org_study_id

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