NCT07738419

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,157

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Apr 2026Jan 2027

Study Start

First participant enrolled

April 27, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

EchocardiographyArtificial IntelligenceDiagnostic Imaging

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    January 2027

Secondary Outcomes (1)

  • Agreement between AI-assisted and expert final echocardiographic diagnoses

    January 2027

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adult patients undergoing clinically indicated standard transthoracic echocardiography at seven high-volume echocardiography laboratories with experienced operators.

You may qualify if:

  • 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.

You may not qualify if:

  • Age \<18 years.
  • Frequent and/or complex cardiac arrhythmias during echocardiographic examination.
  • Suboptimal echocardiographic images.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino, IRCCS

Milan, Lombardy, 20132, Italy

RECRUITING

Central Study Contacts

Laura Fusini, MD

CONTACT

0258002909laura.fusini@cardiologicomonzino.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 31, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations

IT(1)