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Recruiting NCT07620925

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

— Observational Aortic Stenosis Chronic Coronary Syndrome Calcific Aortic Valve Disease Calcific Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiography and Cardiac CT.
Who it may be relevant to
Registry conditions: Aortic Stenosis, Chronic Coronary Syndrome, Calcific Aortic Valve Disease, Calcific Aortic Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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 soft

Primary outcome measures

  • Derivation of Echo-AVCS [Time frame: 6 months]
  • Validation of Echo-AVCS [Time frame: 6 months]
Secondary outcome measures (9)
  • Sex-specific thresholds [Time frame: 6 months]
  • Correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) [Time frame: 6 months]
  • Correlation of the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms [Time frame: 1-year]
  • Association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR) [Time frame: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with the patient's NYHA Class. [Time frame: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with all-cause death at 1-year follow-up. [Time frame: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with cardiovascular death at 1-year follow-up. [Time frame: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with hospitalization for heart failure at 1-year follow-up. [Time frame: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with major adverse cardiovascular events (cardiovascular death and hospitalization for heart failure) at 1-year follow-up. [Time frame: 1 year]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 5 centers
  • University of Bologna — Bologna
  • Centro Cardiologico Monzino — Milan
  • IRCCS Galeazzi-Sant'Amborgio — Milan
  • Politecnico di Milano — Milan
  • Sant'Andrea University Hospital — Roma

Identifiers

NCT: NCT07620925 · 0335/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗