Cardiovascular DiseasesNCT05455541
Reliability of Artificial Intelligence (AI)-Augmented Point-of-care Cardiac Ultrasound in the Hands of Internists
An observational study of Cardiovascular Diseases and Valvular Heart Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The study aim is to test the diagnostic performance of internists interpreting echo images aided by the AISAP CARDIO V0.7 diagnostic support system. Ground truth will be established by an interpretation by cardiologists specialized in echo, of the same POCUS images (acquired by the internist \ sonographer ). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Valvular Heart Disease
- What is being tested?
- AI augmented POCUS examination
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Aug 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients in the internal medicine or geriatrics department that have an accepted indication for a POCUS study
Who may be able to join
- Clinically indicated POCUS cardiac assessment as determined by the treating physicians for an accepted clinical indication
- Willing and able to provide consent for a short partial transthoracic POCCUS examinations
- No urgent or other compelling need for a comprehensive echo exam by the echo lab.
Who cannot join
- Unstable clinical condition that does not permit any reasonable delay necessary to obtain consent and perform the POCCUS
- Severe thoracic deformation or thoracic wall infection or wound that does not permit an adequate echocardiographic examination
- Very poor or non-diagnostic echocardiographic imaging quality on prior echocardiography examinations.
- Patients after lung resection
- Patients unable lie in bed and undergo a standard echo study
- Participation in an interventional study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Robert Klempfner, Prof.
robert.klempfner@sheba.health.gov.il
About this study
Official title: Reliability of Artificial Intelligence (AI)-Augmented Point-of-care Cardiac Ultrasound (POCCUS) in the Hands of Internists
The study aim is to test the diagnostic performance of internists interpreting echo images aided by the AISAP CARDIO V0.7 diagnostic support system. Ground truth will be established by an interpretation by cardiologists specialized in echo, of the same POCUS images (acquired by the internist \ sonographer ).
Up to 1000 subjects; Study population will be distributed according to the following schema:
Group 1 -up to 800 patients hospitalized in the Internal Medicine division Group 2 - up to 200 patients hospitalized in the acute Geriatric division
- Conditions
- Cardiovascular Diseases, Valvular Heart Disease
- Being tested
- AI augmented POCUS examination
- Medical subject headings
- Cardiovascular Diseases, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI augmented POCUS examinationDiagnostic test
Internists will perform POCUS studies as they consider appropriate for patient management. Interpretation of the POCUS exams will be aided by machine learning based analysis of the videos.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients with an indication for POCUS examination | Patient with an accepted indication for point of care echo study that are clinical stable. Receives: Diagnostic Test: AI augmented POCUS examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of agreement
Agreement between the internists AI-aided interpretation and the interpretation by expert cardiologist
Measured: 30 days
Clinical significant findings detected by the internist utilizing AI-aided POCUS
Measured: 30 days
Secondary outcomes (2)
Percent of POCUS images of good quality
Measured: 30 days
Loops that AI interpreted
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start21 Aug 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455541
- Sponsor's protocol ID
- SHEBA-22-9419-KR-CTIL
- Status last verified
- Oct 2023
- First submitted
- 3 Jul 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fisher L, Fiman M, Yarkoni Y, Segal E, Fishman B, Faierstein K, Rubin N, Am-Shalom A, Amital H, Zhao Q, Kort S, Mehrotra P, Schwammenthal E, Klempfner R, Zimlichman E, Raanani E, Maor E. Artificial Intelligence-Enhanced Cardiac Point-of-Care Ultrasound: A Prospective Single-Arm Study. Mayo Clin Proc Digit Health. 2026 Mar 30;4(2):100355. doi: 10.1016/j.mcpdig.2026.100355. eCollection 2026 Jun.
PubMed 42094314Fisher L, Fiman M, Segal E, Lidar S, Rubin N, Am-Shalom A, Cohen I, Faierstein K, Tsur AM, Schwammenthal E, Klempfner R, Zimlichman E, Raanani E, Maor E. Artificial intelligence assessment of valvular disease and ventricular function by a single echocardiography view. Front Digit Health. 2026 Jan 12;7:1684933. doi: 10.3389/fdgth.2025.1684933. eCollection 2025.
PubMed 41602208Faierstein K, Fiman M, Loutati R, Rubin N, Manor U, Am-Shalom A, Cohen-Shelly M, Blank N, Lotan D, Zhao Q, Schwammenthal E, Klempfner R, Zimlichman E, Raanani E, Maor E. Artificial Intelligence Assessment of Biological Age From Transthoracic Echocardiography: Discrepancies with Chronologic Age Predict Significant Excess Mortality. J Am Soc Echocardiogr. 2024 Aug;37(8):725-735. doi: 10.1016/j.echo.2024.04.017. Epub 2024 May 11.
PubMed 38740271
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Artificial Intelligence (AI)-Augmented Point-of-care Cardiac Ultrasound (POCCUS) in the Hands of Internists
- ClinicalTrials.gov ID
- NCT05455541
- Acronym / sponsor ID
- SHEBA-22-9419-KR-CTIL
- Conditions
- Cardiovascular Diseases, Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 21 Aug 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Jul 2022 (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 study aim is to test the diagnostic performance of internists interpreting echo images aided by the AISAP CARDIO V0.7 diagnostic support system. Ground truth will be established by an interpretation by cardiologists specialized in echo, of the same POCUS images (acquired by the internist \ sonographer ).
Up to 1000 subjects; Study population will be distributed according to the following schema:
Group 1 -up to 800 patients hospitalized in the Internal Medicine division Group 2 - up to 200 patients hospitalized in the acute Geriatric division
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients with an indication for POCUS examination | – | Diagnostic Test: AI augmented POCUS examinationPatient with an accepted indication for point of care echo study that are clinical stable. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients in the internal medicine or geriatrics department that have an accepted indication for a POCUS study
Key inclusion criteria (3 listed)
- Clinically indicated POCUS cardiac assessment as determined by the treating physicians for an accepted clinical indication
- Willing and able to provide consent for a short partial transthoracic POCCUS examinations
- No urgent or other compelling need for a comprehensive echo exam by the echo lab.
Key exclusion criteria (6 listed)
- Unstable clinical condition that does not permit any reasonable delay necessary to obtain consent and perform the POCCUS
- Severe thoracic deformation or thoracic wall infection or wound that does not permit an adequate echocardiographic examination
- Very poor or non-diagnostic echocardiographic imaging quality on prior echocardiography examinations.
- Patients after lung resection
- Patients unable lie in bed and undergo a standard echo study
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 |
|---|---|---|
| AI augmented POCUS examinationInternists will perform POCUS studies as they consider appropriate for patient management. Interpretation of the POCUS exams will be aided by machine learning based analysis of the videos. | Diagnostic test | Hospitalized patients with an indication for POCUS examination |
Primary outcome
Degree of agreement
Time frame: 30 days
Agreement between the internists AI-aided interpretation and the interpretation by expert cardiologist
Clinical significant findings detected by the internist utilizing AI-aided POCUS
Time frame: 30 days
2 secondary outcomes
Percent of POCUS images of good quality
Time frame: 30 days
Loops that AI interpreted
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 42094314Fisher L, Fiman M, Yarkoni Y, Segal E, Fishman B, Faierstein K, Rubin N, Am-Shalom A, Amital H, Zhao Q, Kort S, Mehrotra P, Schwammenthal E, Klempfner R, Zimlichman E, Raanani E, Maor E. Artificial Intelligence-Enhanced Cardiac Point-of-Care Ultrasound: A Prospective Single-Arm Study. Mayo Clin Proc Digit Health. 2026 Mar 30;4(2):100355. doi: 10.1016/j.mcpdig.2026.100355. eCollection 2026 Jun.
- Derived from this study: PubMed 41602208Fisher L, Fiman M, Segal E, Lidar S, Rubin N, Am-Shalom A, Cohen I, Faierstein K, Tsur AM, Schwammenthal E, Klempfner R, Zimlichman E, Raanani E, Maor E. Artificial intelligence assessment of valvular disease and ventricular function by a single echocardiography view. Front Digit Health. 2026 Jan 12;7:1684933. doi: 10.3389/fdgth.2025.1684933. eCollection 2025.
- Derived from this study: PubMed 38740271Faierstein K, Fiman M, Loutati R, Rubin N, Manor U, Am-Shalom A, Cohen-Shelly M, Blank N, Lotan D, Zhao Q, Schwammenthal E, Klempfner R, Zimlichman E, Raanani E, Maor E. Artificial Intelligence Assessment of Biological Age From Transthoracic Echocardiography: Discrepancies with Chronologic Age Predict Significant Excess Mortality. J Am Soc Echocardiogr. 2024 Aug;37(8):725-735. doi: 10.1016/j.echo.2024.04.017. Epub 2024 May 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Cardiovascular Diseases and Valvular Heart Disease, run by Sheba Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Klempfner, MD (97235302362, robert.klempfner@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of agreement (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT05455541, which also lists 3 linked publications.
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 3 Jan 2024.