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| Name | Class |
|---|---|
| Politecnico di Milano | OTHER |
| Centro Cardiologico Monzino | OTHER |
| I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio | OTHER |
| University of Bologna |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sex-specific thresholds | To determine sex-specific thresholds (male vs. female) for the echocardiographic aortic valve calcium score (Echo-AVCS). | 6 months |
| Correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuele Barbato, Full Professor | Contact | 0633778763 | emanuele.barbato@uniroma1.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bologna | Recruiting | Bologna | Italy |
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| OTHER |
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|
To assess the correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) measured by cardiac computed tomography. |
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | 1 year |
| Centro Cardiologico Monzino | Recruiting | Milan | Italy |
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| IRCCS Galeazzi-Sant'Amborgio | Recruiting | Milan | Italy |
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| Politecnico di Milano | Active, not recruiting | Milan | Italy |
| Sant'Andrea University Hospital | Recruiting | Roma | Italy |
|
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| C562942 | Aortic Valve, Calcification of |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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