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NCT Number: NCT07620925

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Bologna, Bologna, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Echocardiography and Cardiac CT

Diagnostic Test

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.

Primary outcomes

  1. Derivation of Echo-AVCS

    Time frame: 6 months

    To derive an echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS), using CT-derived aortic valve calcium as the reference standard.

  2. Validation of Echo-AVCS

    Time frame: 6 months

    To validate an echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS), using CT-derived aortic valve calcium as the reference standard.

Secondary outcomes

  1. Sex-specific thresholds

    Time frame: 6 months

    To determine sex-specific thresholds (male vs. female) for the echocardiographic aortic valve calcium score (Echo-AVCS).

  2. Correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³)

    Time frame: 6 months

    To assess the correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) measured by cardiac computed tomography.

  3. Correlation of the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms

    Time frame: 1-year

    To correlate the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms (angina, syncope, and dyspnea).

  4. Association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR)

    Time frame: 1 year

    To evaluate the association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR) according to current ESC Guidelines.

  5. Correlation of the echocardiographic aortic valve calcium score with the patient's NYHA Class.

    Time frame: 1 year

    To correlate the echocardiographic aortic valve calcium score with the patient's NYHA Class.

  6. Correlation of the echocardiographic aortic valve calcium score with all-cause death at 1-year follow-up.

    Time frame: 1 year

    To correlate the echocardiographic aortic valve calcium score with all-cause death at 1-year follow-up.

  7. Correlation of the echocardiographic aortic valve calcium score with cardiovascular death at 1-year follow-up.

    Time frame: 1 year

    To correlate the echocardiographic aortic valve calcium score with cardiovascular death at 1-year follow-up.

  8. Correlation of the echocardiographic aortic valve calcium score with hospitalization for heart failure at 1-year follow-up.

    Time frame: 1 year

    To correlate the echocardiographic aortic valve calcium score with hospitalization for heart failure at 1-year follow-up.

  9. 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

    To correlate the echocardiographic aortic valve calcium score with major adverse cardiovascular events (cardiovascular death and hospitalization for heart failure) at 1-year follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Emanuele Barbato, Full Professor

CONTACT

[email protected]

0633778763

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera "Sant'Andrea"

Other

Collaborators

  • Centro Cardiologico Monzino
  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
  • Politecnico di Milano
  • University of Bologna

Registry information

Acronym: Echo-AVCS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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