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OpenTrials
Completed

NCT Number: NCT04748003

Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study

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.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, Montepllier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence of an a segmental or global acute myocardial dysfunction

    Time frame: In the first week following trauma

    Using transthoracic echocardiography to assess the myocardial function

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Assistance Publique Hopitaux De Marseille

Registry information

Official study 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

Acronym: Strainy trauma

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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