EchocardiographyPANECHONCT07738419
Diagnostic Accuracy of a Deep Learning-Based Software for Automated Multiparametric Echocardiographic Measurements
An observational study of Echocardiography and Artificial Intelligence, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Artificial Intelligence, Diagnostic Imaging
- How many people
- 1,157 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2026to 31 Jan 2027
- 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: Consecutive adult patients undergoing clinically indicated standard transthoracic echocardiography at seven high-volume echocardiography laboratories with experienced operators.
Who may be able to join
- 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.
Who cannot join
- Age <18 years.
- Frequent and/or complex cardiac arrhythmias during echocardiographic examination.
- Suboptimal echocardiographic images.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino, IRCCS
Milan, Lombardy, 20132
Chiara Centenaro, 0258002031 ext. +39, chiara.centenaro@cardiologicomonzino.it
About this study
Official title: 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.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between AI-derived and expert-derived echocardiographic measurements across predefined patient subgroups
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.
Measured: January 2027
Agreement between AI-derived and expert-derived echocardiographic measurements
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.
Measured: Jan 2027
Time required for echocardiographic analysis
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.
Measured: January 2027
Secondary outcomes (1)
Agreement between AI-assisted and expert final echocardiographic diagnoses
Agreement between the final echocardiographic diagnosis suggested by the US2.AI software and the final diagnosis reported by the expert echocardiographer.
Measured: January 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start27 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies 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
- 1,157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Policlinico Modena, Universita di Verona, Monaldi Hospital, Napoli, Italy, ASST Grande Ospedale Metropolitano Niguarda, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Ospedale San Giovanni Evangelista Tivoli
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738419
- Sponsor's protocol ID
- L2-309
- Acronym
- PANECHO
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07738419
- Acronym / sponsor ID
- PANECHO / L2-309
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,157 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Policlinico Modena, Universita di Verona, Monaldi Hospital, Napoli, Italy, ASST Grande Ospedale Metropolitano Niguarda, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Ospedale San Giovanni Evangelista Tivoli
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 31 Jul 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients undergoing clinically indicated standard transthoracic echocardiography at seven high-volume echocardiography laboratories with experienced operators.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Age <18 years.
- Frequent and/or complex cardiac arrhythmias during echocardiographic examination.
- Suboptimal echocardiographic images.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between AI-derived and expert-derived echocardiographic measurements across predefined patient subgroups
Time frame: January 2027
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.
Agreement between AI-derived and expert-derived echocardiographic measurements
Time frame: Jan 2027
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.
Time required for echocardiographic analysis
Time frame: January 2027
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.
1 secondary outcome
Agreement between AI-assisted and expert final echocardiographic diagnoses
Time frame: January 2027
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 31 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography and Artificial Intelligence, run by Centro Cardiologico Monzino at 1 site 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 4 inclusion and 3 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Laura Fusini, MD (0258002909 ext. +39, laura.fusini@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between AI-derived and expert-derived echocardiographic measurements across predefined patient subgroups (time frame: January 2027). The study lists 3 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 31 Jul 2026.