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Can AI read heart scans as well as experts?

NCT ID NCT07738419

Diagnosis Sponsor: Centro Cardiologico Monzino Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study tests whether an AI software called US2.AI can automatically measure heart structure and function from ultrasound videos as accurately as experienced cardiologists. About 1,157 adults undergoing routine heart ultrasounds will have their scans analyzed by both the AI and human experts, and the results will be compared. The goal is to see if AI can speed up analysis and help identify conditions like heart failure or valve disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
US2.AI, an artificial intelligence (deep learning) software that automatically analyzes echocardiographic video clips to measure heart structure and function.
What this could lead to
If successful, this AI could speed up heart ultrasound analysis and help doctors spot conditions like heart failure or valve disease more consistently.
What could go wrong
The AI may not match expert accuracy in all cases, and its performance could vary across different patient groups or image qualities. This is a diagnostic accuracy study, not a treatment trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,157 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Artificial intelligence Diagnostic imaging Echocardiography

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centro Cardiologico Monzino, IRCCS

    RECRUITING

    Milan, Lombardy, 20132, Italy

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