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

NCT07620925 | Recruiting DMC

• 1 other identifier: 0335/2026
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 5

Brief 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

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

Keywords

Aortic stenosis; Low-flow; Aortic valve calcium score; Echocardiography; Cardiac-CT

Outcome Measures

Primary Outcomes (2)

• Derivation of Echo-AVCS

  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.

  6 months

• Validation of Echo-AVCS

  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.

  6 months

Secondary Outcomes (9)

• Sex-specific thresholds

  6 months

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

  6 months

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

  1-year

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

  1 year

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

  1 year

Study Arms (1)

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

Diagnostic Test: Echocardiography and Cardiac CT

Interventions

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.

Patients undergoing transthoracic echocardiography and cardiac-CT with available calcium score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The Echo-CA score Study is an investigator-initiated, prospective, multicenter study of consecutive patients undergoing clinically indicated standard transthoracic echocardiography and cardiac CT with available calcium score performed within 3 months. The study population is expected to include approximately 50% patients with severe AS and 50% without severe AS, in order to ensure a balanced case-control distribution and optimize the precision of diagnostic performance estimates. All patients will be managed according to current standards of care. Clinical evaluation will include systematic collection of cardiovascular risk factors, comorbidities, medical therapy, and detailed symptom assessment (angina, syncope, dyspnea), as well as NYHA functional class. Each participant will undergo: i) comprehensive transthoracic echocardiography (TTE) performed according to current ESC Guideline; ii) cardiac CT with aortic valve calcium quantification, performed according to contemporary acquisiti

You may qualify if:

• Age \> 18 years old
• Clinical indication for standard transthoracic echocardiography.
• Clinical indication for cardiac CT with available calcium score.
• month time interval between transthoracic echocardiography and cardiac CT.
• Able to give informed consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azienda Ospedaliera "Sant'Andrea": lead
• University of Bologna: collaborator
• Politecnico di Milano: collaborator
• Centro Cardiologico Monzino: collaborator
• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: collaborator

Study Sites (5)

University of Bologna

Bologna, Italy

RECRUITING

Centro Cardiologico Monzino

Milan, Italy

RECRUITING

IRCCS Galeazzi-Sant'Amborgio

Milan, Italy

RECRUITING

Politecnico di Milano

Milan, Italy

ACTIVE NOT RECRUITING

Sant'Andrea University Hospital

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve, Calcification of

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Emanuele Barbato, Full Professor

CONTACT

0633778763; emanuele.barbato@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

IT (5)