Diagnostic Accuracy of a Deep Learning-Based Software for Automated Multiparametric Echocardiographic Measurements (PANECHO)
27. juli 2026 opdateret af: Centro Cardiologico Monzino
PANECHO: Diagnostic Accuracy of a Deep Learning-Based Artificial Intelligence Software Developed for Automated Multiparametric Echocardiographic Measurements From Echocardiographic Video Images: A Multicenter Study of the Italian Society of Echocardiography and Cardiovascular Imaging (SIECVI)
Transthoracic echocardiography is an essential imaging modality for the diagnosis and follow-up of cardiovascular diseases.
Comprehensive echocardiographic assessment requires multiple quantitative measurements of cardiac structure and function, which are time-consuming and highly dependent on operator expertise.
US2.AI (Us2.v1) is an artificial intelligence (deep learning)-based software designed to automatically analyze standard two-dimensional and Doppler echocardiographic DICOM video clips acquired from different ultrasound vendors.
The software provides automated measurements of cardiac morphology and function, including chamber dimensions and volumes, left and right ventricular systolic and diastolic function, myocardial strain, and Doppler-derived parameters, generating a comprehensive echocardiographic report based on current international guideline recommendations.
In addition, the software may assist in identifying echocardiographic features suggestive of several cardiovascular conditions, including heart failure, pulmonary hypertension, hypertrophic cardiomyopathy, cardiac amyloidosis, valvular heart disease, and ischemic cardiomyopathy.
Studieoversigt
Status
Rekruttering
Detaljeret beskrivelse
This is a non profit, prospective, multicenter observational study aimed at evaluating the diagnostic accuracy of the US2.AI software by comparing its automated echocardiographic measurements with measurements performed by experienced echocardiographers, considered the reference standard.
The study will assess the agreement between automated and expert-derived measurements and determine the reliability of the software in routine clinical practice. Demonstrating high diagnostic accuracy may support the use of artificial intelligence to standardize echocardiographic measurements and facilitate comprehensive image analysis, particularly in settings where advanced analysis tools or highly experienced operators are not readily available.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
1157
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Laura Fusini, MD
- Telefonnummer: +39 0258002909
- E-mail: laura.fusini@cardiologicomonzino.it
Studiesteder
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Lombardy
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Milan, Lombardy, Italien, 20132
- Rekruttering
- Centro Cardiologico Monzino, IRCCS
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Kontakt:
- Chiara Centenaro
- Telefonnummer: +39 0258002031
- E-mail: chiara.centenaro@cardiologicomonzino.it
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Consecutive adult patients undergoing clinically indicated standard transthoracic echocardiography at seven high-volume echocardiography laboratories with experienced operators.
Beskrivelse
Inclusion Criteria:
- Adults aged 18 years or older.
- Undergoing clinically indicated standard transthoracic echocardiography.
- Adequate echocardiographic image quality for automated and expert analysis.
- Written informed consent provided prior to study participation.
Exclusion Criteria:
- Age <18 years.
- Frequent and/or complex cardiac arrhythmias during echocardiographic examination.
- Suboptimal echocardiographic images.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Prospective Cohort
Consecutive adult patients referred for clinically indicated standard transthoracic echocardiography at seven high-volume echocardiography laboratories will be enrolled.
Echocardiographic examinations will be performed according to routine clinical practice by experienced operators.
Standard two-dimensional, Doppler, and other clinically indicated measurements required for the diagnostic report will be obtained manually by expert echocardiographers and automatically by the artificial intelligence software (US2.AI).
No additional study-specific imaging procedures or follow-up visits are planned.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Agreement between AI-derived and expert-derived echocardiographic measurements across predefined patient subgroups
Tidsramme: January 2027
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Comparison of the agreement between automated and expert-derived measurements in predefined subgroups, including participants with normal echocardiographic findings and those with specific cardiovascular diseases.
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January 2027
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Agreement between AI-derived and expert-derived echocardiographic measurements
Tidsramme: Jan 2027
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Agreement between automated echocardiographic measurements generated by the US2.AI software and manual measurements performed by experienced echocardiographers (reference standard) across standard two-dimensional, Doppler, and strain parameters.
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Jan 2027
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Time required for echocardiographic analysis
Tidsramme: January 2027
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Comparison of the time required to obtain a complete set of echocardiographic measurements using manual analysis by experienced echocardiographers versus automated analysis by the US2.AI software.
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January 2027
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Agreement between AI-assisted and expert final echocardiographic diagnoses
Tidsramme: January 2027
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Agreement between the final echocardiographic diagnosis suggested by the US2.AI software and the final diagnosis reported by the expert echocardiographer.
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January 2027
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. april 2026
Primær færdiggørelse (Anslået)
31. januar 2027
Studieafslutning (Anslået)
31. januar 2027
Datoer for studieregistrering
Først indsendt
27. juli 2026
Først indsendt, der opfyldte QC-kriterier
27. juli 2026
Først opslået (Faktiske)
31. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- L2-309
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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