Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-28 @ 3:37 AM
Study NCT ID:
NCT04748003
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2021-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of an a segmental or global acute myocardial dysfunction', 'timeFrame': 'In the first week following trauma', 'description': 'Using transthoracic echocardiography to assess the myocardial function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe trauma', 'chest trauma'], 'conditions': ['Chest Trauma']}, 'descriptionModule': {'briefSummary': '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.\n\nThe measurement of myocardial strain (2D-strain) by transthoracic sonography is a robust tool to assess the myocardial function.\n\nThe 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.', 'detailedDescription': 'Thoracic trauma is the cause of significant morbidity and accounts for 25% of trauma-related deaths.\n\nThe 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.\n\nOtherwise, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severe trauma patients with blunt chest trauma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe trauma patients with blunt chest trauma\n* (AIS Thorax score ≥ 1)\n* admitted in our trauma intensive care unit\n* and included within the 24 first hours following trauma\n\nExclusion Criteria:\n\n* Imminent death\n* Recovered cardiocirculatory arrest following trauma\n* Critical patient : AIS score ≥5 on 1 lesion, requiring ECLS (extracorporeal life support) or REBOA (resuscitative endovascular balloon occlusion of the aorta)\n* Refractory hypovolaemia\n* Arrhythmia, atrial fibrillation\n* Congenital heart disease, ischemic cardiomyopathy, moderate or severe pre-existing valvular heart disease, pulmonary arterial hypertension (PAH)\n* Valve prosthesis or pacemaker\n* Insufficient quality of ultrasound image to allow correct assessment of 2D-strain\n* Pregnant woman and underage patients'}, 'identificationModule': {'nctId': 'NCT04748003', 'acronym': 'Strainy trauma', 'briefTitle': 'Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RECHMPL20_0380'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'Montepllier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Jonathan CHARBIT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}