Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study

NCT04748003 | Completed

• 1 other identifier: RECHMPL20_0380
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Trauma

Keywords

Severe trauma; chest trauma

Outcome Measures

Primary Outcomes (1)

• Occurrence of an a segmental or global acute myocardial dysfunction

  Using transthoracic echocardiography to assess the myocardial function

  In the first week following trauma

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe trauma patients with blunt chest trauma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Assistance Publique Hopitaux De Marseille: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, Montepllier, 34295, France

Location

MeSH Terms

Conditions

Thoracic Injuries; Wounds and Injuries

Study Officials

• Jonathan CHARBIT, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: February 28, 2021
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

FR (1)