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

Recruitingn/aAges 18 Years - anyAllAzienda Ospedaliera "Sant'Andrea"
NCT07620925 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 b

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📋 Eligibility rules (as published)
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).
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What it tests

  • Echocardiography and Cardiac CT
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Where

5 sites
University of Bologna
Bologna, Italy
Centro Cardiologico Monzino
Milan, Italy
IRCCS Galeazzi-Sant'Amborgio
Milan, Italy
Politecnico di Milano
Milan, Italy
Sant'Andrea University Hospital
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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