Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study
Key facts
- Who runs it
- Azienda Ospedaliera "Sant'Andrea"
- Where
- Italy5 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 250 people, planned
- Started
- 1 Mar 2026
- Expected to end
- 31 Dec 2027
- Type of study
- Observational
- Treatments tested
- Echocardiography and Cardiac CT
- Record updated
- 4 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Poor quality cardiac CT, inadequate for standard calcium score assessment
- Patients with inadequate transthoracic echocardiographic images
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Patients undergoing transthoracic echocardiography and cardiac-CT with available calcium score
Consecutive patients undergoing clinically indicated standard transthoracic echocardiography and cardiac CT with available calcium score performed within 3 months
Treatment: Echocardiography and Cardiac CT
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 June 2026