Aortic StenosisEcho-AVCSNCT07620925
Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study
An observational study of Aortic Stenosis and Chronic Coronary Syndrome, run by Azienda Ospedaliera "Sant'Andrea" at 5 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Chronic Coronary Syndrome, Calcific Aortic Valve Disease
- What is being tested?
- Echocardiography and Cardiac CT
- How many people
- 250 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Mar 2026to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 4 recruiting
- Recruiting
University of Bologna
Bologna
Carmine Pizzi, carmine.pizzi@unibo.it
Luca Bergamaschi
- Recruiting
Centro Cardiologico Monzino
Milan
Gianluca Pontone, 02 58002574, gianluca.pontone@cardiologicomonzino.it
Saima Mushtaq, MD, PhD
- Recruiting
IRCCS Galeazzi-Sant'Amborgio
Milan
Edoardo Conte, edoardo.conte86@gmail.com
Tommaso Viva
- Active, not recruiting
Politecnico di Milano
Milan
- Recruiting
Sant'Andrea University Hospital
Roma
Emanuele Barbato, Full Professor, 0633778763, emanuele.barbato@uniroma1.it
Pasquale Paolisso, MD, PhD, pasquale.paolisso@gmail.com
About this study
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
- Aortic Stenosis, Chronic Coronary Syndrome, Calcific Aortic Valve Disease, Calcific Aortic Stenosis
- Being tested
- Echocardiography and Cardiac CT
- Keywords
- Aortic stenosis, Low-flow, Aortic valve calcium score, Echocardiography, Cardiac-CT
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography and Cardiac CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Echocardiography and Cardiac CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (9)
Sex-specific thresholds
To determine sex-specific thresholds (male vs. female) for the echocardiographic aortic valve calcium score (Echo-AVCS).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera "Sant'Andrea"
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano, Centro Cardiologico Monzino, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, University of Bologna
- Responsible party
- Principal investigator, Emanuele Barbato, Azienda Ospedaliera "Sant'Andrea"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620925
- Sponsor's protocol ID
- 0335/2026
- Acronym
- Echo-AVCS
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study
- ClinicalTrials.gov ID
- NCT07620925
- Acronym / sponsor ID
- Echo-AVCS / 0335/2026
- Conditions
- Aortic Stenosis, Chronic Coronary Syndrome, Calcific Aortic Valve Disease, Calcific Aortic Stenosis
- Keywords
- Aortic stenosis, Low-flow, Aortic valve calcium score, Echocardiography, Cardiac-CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera "Sant'Andrea"University, hospital or other
- Collaborators
- Politecnico di Milano, Centro Cardiologico Monzino, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, University of Bologna
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing transthoracic echocardiography and cardiac-CT with available calcium score | – | Diagnostic Test: Echocardiography and Cardiac CTConsecutive patients undergoing clinically indicated standard transthoracic echocardiography and cardiac CT with available calcium score performed within 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography and Cardiac CTThis 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. | Diagnostic test | Patients undergoing transthoracic echocardiography and cardiac-CT with available calcium score |
Primary outcome
Derivation of Echo-AVCS
Time frame: 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
Time frame: 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.
9 secondary outcomes
Sex-specific thresholds
Time frame: 6 months
Correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³)
Time frame: 6 months
Correlation of the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms
Time frame: 1-year
Association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR)
Time frame: 1 year
Correlation of 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.
Time frame: 1 year
Correlation of 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.
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.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Chronic Coronary Syndrome, run by Azienda Ospedaliera "Sant'Andrea" at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Barbato, Full Professor (0633778763, emanuele.barbato@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Derivation of Echo-AVCS (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.