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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

250

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Italia
      • Bologna, Italia
        • Rekruttering
        • University of Bologna
        • Ta kontakt med:
        • Underetterforsker:
          • Luca Bergamaschi
        • Underetterforsker:
          • Matteo Armillotta
        • Underetterforsker:
          • Francesco Angeli
      • Milan, Italia
        • Rekruttering
        • Centro Cardiologico Monzino
        • Ta kontakt med:
        • Underetterforsker:
          • Saima Mushtaq, MD, PhD
        • Underetterforsker:
          • Maria Elisabetta Mancini, MD
      • Milan, Italia
        • Rekruttering
        • IRCCS Galeazzi-Sant'Amborgio
        • Ta kontakt med:
        • Underetterforsker:
          • Tommaso Viva
        • Underetterforsker:
          • Davide Marchetti
      • Milan, Italia
        • Aktiv, ikke rekrutterende
        • Politecnico di Milano
      • Roma, Italia
        • Rekruttering
        • Sant'Andrea University Hospital
        • Underetterforsker:
          • Pasquale Paolisso, MD, PhD
        • Underetterforsker:
          • Marta Belmonte, MD, PhD
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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
Diagnostisk test: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Derivation of Echo-AVCS
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sex-specific thresholds
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Azienda Ospedaliera "Sant'Andrea"

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

27. mai 2026

Først innsendt som oppfylte QC-kriteriene

27. mai 2026

Først lagt ut (Faktiske)

2. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0335/2026

Plan for individuelle deltakerdata (IPD)

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Nei

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