Aortic Stenosis, Calcific Aortic Stenosis, Calcific Aortic Valve Disease, Chronic Coronary Syndrome
Conditions
Keywords
Aortic stenosis, Low-flow, Aortic valve calcium score, Echocardiography, Cardiac-CT
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.
Interventions
DIAGNOSTIC_TESTEchocardiography 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 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.
Sponsors
Azienda Ospedaliera "Sant'Andrea"
Politecnico di Milano
Centro Cardiologico Monzino
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
University of Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Derivation of Echo-AVCS | 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. |
| Validation of Echo-AVCS | 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
| Measure | Time frame | Description |
|---|---|---|
| Sex-specific thresholds | 6 months | To determine sex-specific thresholds (male vs. female) for the echocardiographic aortic valve calcium score (Echo-AVCS). |
| Correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) | 6 months | To assess the correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) measured by cardiac computed tomography. |
| Correlation of the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms | 1-year | To correlate the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms (angina, syncope, and dyspnea). |
| Association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR) | 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. |
| Correlation of the echocardiographic aortic valve calcium score with the patient's NYHA Class. | 1 year | To correlate the echocardiographic aortic valve calcium score with the patient's NYHA Class. |
| Correlation of the echocardiographic aortic valve calcium score with all-cause death at 1-year follow-up. | 1 year | To correlate the echocardiographic aortic valve calcium score with all-cause death at 1-year follow-up. |
| Correlation of the echocardiographic aortic valve calcium score with cardiovascular death at 1-year follow-up. | 1 year | To correlate the echocardiographic aortic valve calcium score with cardiovascular death at 1-year follow-up. |
| Correlation of the echocardiographic aortic valve calcium score with hospitalization for heart failure at 1-year follow-up. | 1 year | To correlate the echocardiographic aortic valve calcium score with hospitalization for heart failure at 1-year follow-up. |
| 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. | 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. |
Countries
Italy
Contacts
CONTACTEmanuele Barbato, Full Professor
Outcome results
None listed