An observational study in Echocardiography, Artificial Intelligence and Diagnostic Imaging, sponsored by Centro Cardiologico Monzino. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Centro Cardiologico Monzino · Observational
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.
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.
Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adult patients undergoing clinically indicated standard transthoracic echocardiography at seven high-volume echocardiography laboratories with experienced operators.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Agreement between AI-derived and expert-derived echocardiographic measurements across predefined patient subgroups
Comparison of the agreement between automated and expert-derived measurements in predefined subgroups, including participants with normal echocardiographic findings and those with specific cardiovascular diseases.
Time frame: January 2027
Agreement between AI-derived and expert-derived echocardiographic measurements
Agreement between automated echocardiographic measurements generated by the US2.AI software and manual measurements performed by experienced echocardiographers (reference standard) across standard two-dimensional, Doppler, and strain parameters.
Time frame: Jan 2027
Time required for echocardiographic analysis
Comparison of the time required to obtain a complete set of echocardiographic measurements using manual analysis by experienced echocardiographers versus automated analysis by the US2.AI software.
Time frame: January 2027
Agreement between AI-assisted and expert final echocardiographic diagnoses
Agreement between the final echocardiographic diagnosis suggested by the US2.AI software and the final diagnosis reported by the expert echocardiographer.
Time frame: January 2027
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Centro Cardiologico Monzino