Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study designed to derive and validate an AI-driven echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis. Participants are adults undergoing standard transthoracic echocardiography and a cardiac CT calcium score within a three-month window. Standardized echocardiographic images will be centrally analyzed using AI-based image segmentation and machine learning to correlate with CT calcium scoring and diagnostic certainty, potentially reducing reliance on CT and radiation. The study addresses cases where echocardiographic measures of stenosis are discordant or low-flow, offering a data-driven approach to improve diagnostic confidence. Interventions involve routine echocardiography and cardiac CT imaging; no experimental treatments are given.

Why it matters

Who can join: the full rules

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).

Where it's running

• University of Bologna
  Bologna, Italy Recruiting
• Centro Cardiologico Monzino
  Milan, Italy Recruiting
• IRCCS Galeazzi-Sant'Amborgio
  Milan, Italy Recruiting
• Sant'Andrea University Hospital
  Roma, Italy Recruiting
• Politecnico di Milano
  Milan, Italy Active not recruiting

Study contacts

• Study coordinator: Emanuele Barbato, Full Professor
• Email: emanuele.barbato@uniroma1.it
• Phone: 0633778763

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.