Strainy trauma: Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04748003
Collaborator
Assistance Publique Hopitaux De Marseille (Other)
150
1

Study Details

Study Description

Brief Summary

This study aims to investigate whether the identification of acute myocardial dysfunction by 2D-strain transthoracic sonography in the first week following trauma would allow to better diagnose occult and severe patterns of myocardial contusion, in order to identify a subpopulation at higher risk of complications.

The measurement of myocardial strain (2D-strain) by transthoracic sonography is a robust tool to assess the myocardial function.

The investigators strongly suppose that the 2D-strain would allow to better identify subclinical MC in chest trauma, as well as the severe patterns that are associated with more organs dysfunctions and a worst outcome.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thoracic trauma is the cause of significant morbidity and accounts for 25% of trauma-related deaths.

    The myocardial contusion (MC) is a distinct injury, which has a prevalence increasing with the severity of the trauma. The diagnostic tool is a major factor to vary the prevalence of MC (i.e. clinical exam, biology, electrocardiogram), with the highest values for autopsy series, until 24% of patients. It does not exist therefore of gold standard for the diagnosis of MC in clinical practice leading to a modest knowledge of this nosological entity. In clinical practice, troponin plasma level determines the diagnostic.

    Otherwise, the measurement of myocardial strain (2D-strain) by transthoracic echocardiography (TTE) is a robust tool to assess the myocardial function. This ultrasound analysis allows an objective and topographical quantification of an acute myocardial dysfunction, be it global or segmental. 2D-strain has been thus has been validated for the diagnosis of myocardial dysfunction in medical setting. Its use in trauma setting has never been reported.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Prevalence and Prognostic Value of Acute Myocardial Dysfunction in Severe Trauma Patients With Chest Trauma Using 2D-strain Ultrasound: A Prospective Observational Study
    Actual Study Start Date :
    Feb 28, 2021
    Actual Primary Completion Date :
    Feb 28, 2021
    Actual Study Completion Date :
    Feb 28, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of an a segmental or global acute myocardial dysfunction [In the first week following trauma]

      Using transthoracic echocardiography to assess the myocardial function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • severe trauma patients with blunt chest trauma

    • (AIS Thorax score ≥ 1)

    • admitted in our trauma intensive care unit

    • and included within the 24 first hours following trauma

    Exclusion Criteria:
    • Imminent death

    • Recovered cardiocirculatory arrest following trauma

    • Critical patient : AIS score ≥5 on 1 lesion, requiring ECLS (extracorporeal life support) or REBOA (resuscitative endovascular balloon occlusion of the aorta)

    • Refractory hypovolaemia

    • Arrhythmia, atrial fibrillation

    • Congenital heart disease, ischemic cardiomyopathy, moderate or severe pre-existing valvular heart disease, pulmonary arterial hypertension (PAH)

    • Valve prosthesis or pacemaker

    • Insufficient quality of ultrasound image to allow correct assessment of 2D-strain

    • Pregnant woman and underage patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier Montepllier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier
    • Assistance Publique Hopitaux De Marseille

    Investigators

    • Principal Investigator: Jonathan CHARBIT, MD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04748003
    Other Study ID Numbers:
    • RECHMPL20_0380
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022