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

3 juni 2026 bijgewerkt door: Emanuele Barbato, Azienda Ospedaliera "Sant'Andrea"
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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

250

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Italië
      • Bologna, Italië
        • Werving
        • University of Bologna
        • Contact:
        • Onderonderzoeker:
          • Luca Bergamaschi
        • Onderonderzoeker:
          • Matteo Armillotta
        • Onderonderzoeker:
          • Francesco Angeli
      • Milan, Italië
        • Werving
        • Centro Cardiologico Monzino
        • Contact:
        • Onderonderzoeker:
          • Saima Mushtaq, MD, PhD
        • Onderonderzoeker:
          • Maria Elisabetta Mancini, MD
      • Milan, Italië
        • Werving
        • IRCCS Galeazzi-Sant'Amborgio
        • Contact:
        • Onderonderzoeker:
          • Tommaso Viva
        • Onderonderzoeker:
          • Davide Marchetti
      • Milan, Italië
        • Actief, niet wervend
        • Politecnico di Milano
      • Roma, Italië
        • Werving
        • Sant'Andrea University Hospital
        • Onderonderzoeker:
          • Pasquale Paolisso, MD, PhD
        • Onderonderzoeker:
          • Marta Belmonte, MD, PhD
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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
Diagnostische toets: Echocardiography 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Derivation of Echo-AVCS
Tijdsspanne: 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.
6 months
Validation of Echo-AVCS
Tijdsspanne: 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.
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sex-specific thresholds
Tijdsspanne: 6 months
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)
Tijdsspanne: 6 months
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
Tijdsspanne: 1-year
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)
Tijdsspanne: 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.
1 year
Correlation of the echocardiographic aortic valve calcium score with the patient's NYHA Class.
Tijdsspanne: 1 year
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.
Tijdsspanne: 1 year
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.
Tijdsspanne: 1 year
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.
Tijdsspanne: 1 year
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.
Tijdsspanne: 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.
1 year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Azienda Ospedaliera "Sant'Andrea"

Medewerkers

University of Bologna
Politecnico di Milano
Centro Cardiologico Monzino
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 mei 2026

Eerst geplaatst (Werkelijk)

2 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0335/2026

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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