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PANECHO: Diagnostic Accuracy of a Deep Learning-Based Artificial Intelligence Software Developed for Automated Multiparametric Echocardiographic Measurements From Echocardiographic Video Images: A Multicenter Study of the Italian Society of Echocardiography and Cardiovascular Imaging (SIECVI)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Centro Cardiologico Monzino, IRCCS
RECRUITING
Milan
Contact Information
Primary
Laura Fusini, MD
laura.fusini@cardiologicomonzino.it
0258002909
Time Frame
Start Date: 2026-04-27
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 1157
Treatments
Prospective Cohort
Consecutive adult patients referred for clinically indicated standard transthoracic echocardiography at seven high-volume echocardiography laboratories will be enrolled. Echocardiographic examinations will be performed according to routine clinical practice by experienced operators. Standard two-dimensional, Doppler, and other clinically indicated measurements required for the diagnostic report will be obtained manually by expert echocardiographers and automatically by the artificial intelligence software (US2.AI). No additional study-specific imaging procedures or follow-up visits are planned.
Sponsors
Leads: Centro Cardiologico Monzino
Collaborators: Azienda Ospedaliero Universitaria Policlinico Modena, Azienda Ospedaliera Universitaria Policlinico G. Martino, Ospedale San Giovanni Evangelista Tivoli, Monaldi Hospital, Napoli, Italy, ASST Grande Ospedale Metropolitano Niguarda, Universita di Verona

This content was sourced from clinicaltrials.gov