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.
Study Type
OBSERVATIONAL
Enrollment
250
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.
University of Bologna
Bologna, Italy
RECRUITINGCentro Cardiologico Monzino
Milan, Italy
RECRUITINGIRCCS Galeazzi-Sant'Amborgio
Milan, Italy
RECRUITINGPolitecnico di Milano
Milan, Italy
ACTIVE_NOT_RECRUITINGSant'Andrea University Hospital
Roma, Italy
RECRUITINGDerivation 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.
Time frame: 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.
Time frame: 6 months
Sex-specific thresholds
To determine sex-specific thresholds (male vs. female) for the echocardiographic aortic valve calcium score (Echo-AVCS).
Time frame: 6 months
Correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³)
To assess the correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) measured by cardiac computed tomography.
Time frame: 6 months
Correlation of the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms
To correlate the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms (angina, syncope, and dyspnea).
Time frame: 1-year
Association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR)
To evaluate the association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR) according to current ESC Guidelines.
Time frame: 1 year
Correlation of the echocardiographic aortic valve calcium score with the patient's NYHA Class.
To correlate 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.
To correlate 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.
To correlate 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.
To correlate 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.
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.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.