Diagnostic Accuracy of a Deep Learning-Based Software for Automated Multiparametric Echocardiographic Measurements

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

About this trial

Transthoracic echocardiography is an essential imaging modality for the diagnosis and follow-up of cardiovascular diseases. Comprehensive echocardiographic assessment requires multiple quantitative measurements of cardiac structure and function, which are time-consuming and highly dependent on operator expertise. US2.AI (Us2.v1) is an artificial intelligence (deep learning)-based software designed to automatically analyze standard two-dimensional and Doppler echocardiographic DICOM video clips acquired from different ultrasound vendors. The software provides automated measurements of cardiac morphology and function, including chamber dimensions and volumes, left and right ventricular systolic and diastolic function, myocardial strain, and Doppler-derived parameters, generating a comprehensive echocardiographic report based on current international guideline recommendations. In addition, the software may assist in identifying echocardiographic features suggestive of several cardiovascular conditions, including heart failure, pulmonary hypertension, hypertrophic cardiomyopathy, cardiac amyloidosis, valvular heart disease, and ischemic cardiomyopathy.

Eligibility criteria

Qualifiers

Adults aged 18 years or older.

Undergoing clinically indicated standard transthoracic echocardiography.

Adequate echocardiographic image quality for automated and expert analysis.

Written informed consent provided prior to study participation.

Disqualifiers

Age <18 years.

Frequent and/or complex cardiac arrhythmias during echocardiographic examination.

Suboptimal echocardiographic images.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,157 Participants
are grouped into 1 trial group

Sponsors and collaborators

Centro Cardiologico Monzino

Lead sponsor

Azienda Ospedaliero Universitaria Policlinico Modena

Collaborator

Universita di Verona

Collaborator

Monaldi Hospital, Napoli, Italy

Collaborator

ASST Grande Ospedale Metropolitano Niguarda

Collaborator

Policlinico G . Martino, Messina Italy

Collaborator

Ospedale San Giovanni Evangelista Tivoli

Collaborator