Diagnostic Accuracy of a Deep Learning-Based Software for Automated Multiparametric Echocardiographic Measurements | NCT07738419

NCT07738419

Overview

NCT ID: NCT07738419
Lead Sponsor: Centro Cardiologico MonzinoOTHER
Official Title: 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)
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Apr 27, 2026Actual
Primary Completion Date: Jan 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Age <18 years.

Frequent and/or complex cardiac arrhythmias during echocardiographic examination.

Suboptimal echocardiographic images.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 1,157Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Laura Fusini, MDContact
laura.fusini@cardiologicomonzino.it0258002909 ext. +39

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Participant Group/Arms

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.