Chest TraumaStrainy traumaNCT04748003
Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study
An observational study of Chest Trauma, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Chest Trauma
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2021to 28 Feb 2021
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe trauma patients with blunt chest trauma
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Valve prosthesis or pacemaker
- Insufficient quality of ultrasound image to allow correct assessment of 2D-strain
- Pregnant woman and underage patients
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chest Trauma
- Keywords
- Severe trauma, chest trauma
- Medical subject headings
- Thoracic Injuries, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of an a segmental or global acute myocardial dysfunction
Using transthoracic echocardiography to assess the myocardial function
Measured: In the first week following trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start28 Feb 2021
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TraumaStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
- Investigators
- Jonathan CHARBIT, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748003
- Sponsor's protocol ID
- RECHMPL20_0380
- Acronym
- Strainy trauma
- Status last verified
- Mar 2022
- First submitted
- 5 Feb 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04748003
- Acronym / sponsor ID
- Strainy trauma / RECHMPL20_0380
- Conditions
- Chest Trauma
- Keywords
- Severe trauma, chest trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 10 Feb 2021 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe trauma patients with blunt chest trauma
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Chest Trauma
RecruitingObservational study
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
Small Cell Lung Cancer ( SCLC ), Brain Injury
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
Not yet recruitingObservational study
Results of Medical and Nursing Record,Physical Examination, Blood Test and Radiological Examination of Multiple Trauma to Find the Correlation With Patient's Morality and Mobility
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
RecruitingPhase 1
Safety of CRT100 on Treatment Spinal Cord Injury
Thoracic Spinal Cord Injury
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.
Jonathan CHARBIT, MD principal investigator
University Hospital, Montpellier
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 Chest Trauma, run by University Hospital, Montpellier at 1 site in France.
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 9 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: finished, as of the sponsor's last update on 7 Apr 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of an a segmental or global acute myocardial dysfunction (time frame: In the first week following trauma). 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 7 Apr 2022.