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Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study

NCT07620925 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-06-04

No results posted yet for this study

Summary

The Echo-AVCS Study is an investigator-initiated, prospective, multicenter observational study designed to derive and validate an artificial intelligence (AI)-based echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS). Transthoracic echocardiography (TTE) is the standard imaging modality for assessing AS severity; however, discrepancies between valve area and transvalvular gradient measurements may complicate diagnosis, particularly in low-flow or discordant AS presentations. Cardiac computed tomography (CT)-derived aortic valve calcium scoring is currently used to resolve diagnostic uncertainty, but it involves additional cost and radiation exposure. This study will enroll consecutive adult patients undergoing clinically indicated TTE and cardiac CT with calcium scoring performed within 3 months. Standardized echocardiographic images will be centrally analyzed using dedicated AI-based image segmentation and machine learning methods to quantify aortic valve calcification directly from TTE images. CT-derived aortic valve calcium score will serve as the reference standard. The primary objective is to derive and validate the Echo-AVCS score for identifying severe AS. Secondary objectives include determination of sex-specific diagnostic thresholds, correlation with CT calcium volume, association with symptoms and NYHA class, and evaluation of prognostic associations with aortic valve replacement, heart failure hospitalization, cardiovascular events, and mortality at 1-year follow-up.

Conditions

  • Aortic Stenosis
  • Chronic Coronary Syndrome
  • Calcific Aortic Valve Disease
  • Calcific Aortic Stenosis

Interventions

DIAGNOSTIC_TEST

Echocardiography and Cardiac CT

This is a non-interventional, observational study in which all patients will undergo clinically indicated standard-of-care transthoracic echocardiography (TTE) and cardiac computed tomography (CT) with aortic valve calcium scoring. No investigational drug, device, or additional invasive procedure will be administered as part of the study. Echocardiographic images acquired during routine clinical practice will be anonymized and centrally analyzed using dedicated artificial intelligence-based software to derive and validate the echocardiographic aortic valve calcium score. Patient management, follow-up, and therapeutic decisions, including referral for aortic valve replacement, will remain entirely at the discretion of the treating physicians according to current clinical guidelines and standard practice.

Sponsors & Collaborators

  • Politecnico di Milano

    collaborator OTHER

  • Centro Cardiologico Monzino

    collaborator OTHER

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    collaborator OTHER

  • University of Bologna

    collaborator OTHER

  • Azienda Ospedaliera "Sant'Andrea"

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620925 on ClinicalTrials.gov