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AI-Powered ultrasound could replace CT for heart valve diagnosis

NCT ID NCT07620925

Diagnosis Sponsor: Azienda Ospedaliera "Sant'Andrea" 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether artificial intelligence can analyze standard ultrasound images of the heart to measure calcium buildup on the aortic valve. If accurate, this could help doctors diagnose severe aortic stenosis without the extra cost and radiation of a CT scan. The study will enroll 250 adults who need both an ultrasound and a CT scan for clinical reasons.

What this could mean

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

What this could lead to
If successful, this could provide a cheaper, radiation-free way to diagnose severe aortic stenosis using only ultrasound and AI.
What could go wrong
This is an observational study, not a treatment trial. The AI may not be accurate enough to replace CT scans, and results may not apply to all patients.

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 250 people

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

Started

Mar 2026

Expected to finish

Dec 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

The Echo-CA score Study is an investigator-initiated, prospective, multicenter study of consecutive patients undergoing clinically indicated standard transthoracic echocardiography and cardiac CT with available calcium score performed within 3 months. The study population is expected to include approximately 50% patients with severe AS and 50% without severe AS, in order to ensure a balanced case-control distribution and optimize the precision of diagnostic performance estimates. All patients will be managed according to current standards of care. Clinical evaluation will include systematic collection of cardiovascular risk factors, comorbidities, medical therapy, and detailed symptom assessment (angina, syncope, dyspnea), as well as NYHA functional class. Each participant will undergo: i) comprehensive transthoracic echocardiography (TTE) performed according to current ESC Guideline; ii) cardiac CT with aortic valve calcium quantification, performed according to contemporary acquisiti

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: * Age \> 18 years old * Clinical indication for standard transthoracic echocardiography. * Clinical indication for cardiac CT with available calcium score. * 3-month time interval between transthoracic echocardiography and cardiac CT. * Able to give informed consent. Exclusion Criteria: * Patients with inadequate transthoracic echocardiographic images. * Poor quality cardiac CT, inadequate for standard calcium score assessment. * Patients with known prior stents and/or coronary artery bypass grafts. * Patients with known previous percutaneous or surgical aortic valve replacement. * Patients with active or a history of endocarditis. * Patients with congenital heart defects (other than isolated bicuspid aortic valve).

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Conditions

The condition(s) this trial relates to.

aortic valve calcification aortic valve stenosis Aortic Valve, Calcification of

As listed by the trial registrant

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

Aortic stenosis Calcific aortic stenosis Calcific aortic valve disease Chronic coronary syndrome

How to take part

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

  1. The places running it

    4 sites. 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

    RECRUITING

    Milan, Italy

  • IRCCS Galeazzi-Sant'Amborgio

    RECRUITING

    Milan, Italy

  • Politecnico di Milano

    ACTIVE_NOT_RECRUITING

    Milan, Italy

  • Sant'Andrea University Hospital

    RECRUITING

    Roma, Italy

  • University of Bologna

    RECRUITING

    Bologna, Italy

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