Menu
Recruiting NCT07738419

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

— Observational Echocardiography Artificial Intelligence Diagnostic Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Echocardiography, Artificial Intelligence, Diagnostic Imaging. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Detailed description

This is a non profit, prospective, multicenter observational study aimed at evaluating the diagnostic accuracy of the US2.AI software by comparing its automated echocardiographic measurements with measurements performed by experienced echocardiographers, considered the reference standard.

The study will assess the agreement between automated and expert-derived measurements and determine the reliability of the software in routine clinical practice. Demonstrating high diagnostic accuracy may support the use of artificial intelligence to standardize echocardiographic measurements and facilitate comprehensive image analysis, particularly in settings where advanced analysis tools or highly experienced operators are not readily available.

Primary outcome measures

  • Agreement between AI-derived and expert-derived echocardiographic measurements across predefined patient subgroups [Time frame: January 2027]
  • Agreement between AI-derived and expert-derived echocardiographic measurements [Time frame: Jan 2027]
  • Time required for echocardiographic analysis [Time frame: January 2027]
Secondary outcome measures (1)
  • Agreement between AI-assisted and expert final echocardiographic diagnoses [Time frame: January 2027]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Centro Cardiologico Monzino, IRCCS — Milan

Identifiers

NCT: NCT07738419 · L2-309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗