NCT07738419 Diagnostic Accuracy of a Deep Learning-Based Software for Automated Multiparametric Echocardiographic Measurements
| NCT ID | NCT07738419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro Cardiologico Monzino |
| Condition | Echocardiography |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,157 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,157 participants in total. It began in 2026-04-27 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07738419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Echocardiography. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07738419 currently recruiting?
Yes, NCT07738419 is actively recruiting participants. Contact the research team at laura.fusini@cardiologicomonzino.it for enrollment information.
Where is the NCT07738419 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07738419 clinical trial?
NCT07738419 is sponsored by Centro Cardiologico Monzino. The trial plans to enroll 1,157 participants.