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

NCT07738419 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1157

Last updated 2026-07-31

No results posted yet for this study

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.

Conditions

  • Echocardiography
  • Artificial Intelligence
  • Diagnostic Imaging

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria Policlinico Modena

    collaborator OTHER

  • Universita di Verona

    collaborator OTHER

  • Monaldi Hospital, Napoli, Italy

    collaborator UNKNOWN

  • ASST Grande Ospedale Metropolitano Niguarda

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"

    collaborator OTHER

  • Ospedale San Giovanni Evangelista Tivoli

    collaborator UNKNOWN

  • Centro Cardiologico Monzino

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-27
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07738419 on ClinicalTrials.gov