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Reliability of Artificial Intelligence (AI)-Augmented Point-of-care Cardiac Ultrasound in the Hands of Internists

Reliability of Artificial Intelligence (AI)-Augmented Point-of-care Cardiac Ultrasound (POCCUS) in the Hands of Internists

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05455541
Enrollment
300
Registered
2022-07-13
Start date
2022-08-21
Completion date
2023-12-31
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Valvular Heart Disease

Brief 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 ). 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

Interventions

DIAGNOSTIC_TESTAI augmented POCUS examination

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.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Clinically indicated POCUS cardiac assessment as determined by the treating physicians for an accepted clinical indication 2. Willing and able to provide consent for a short partial transthoracic POCCUS examinations 3. No urgent or other compelling need for a comprehensive echo exam by the echo lab.

Exclusion criteria

1. Unstable clinical condition that does not permit any reasonable delay necessary to obtain consent and perform the POCCUS 2. Severe thoracic deformation or thoracic wall infection or wound that does not permit an adequate echocardiographic examination 3. Very poor or non-diagnostic echocardiographic imaging quality on prior echocardiography examinations. 4. Patients after lung resection 5. Patients unable lie in bed and undergo a standard echo study 6. Participation in an interventional study

Design outcomes

Primary

MeasureTime frameDescription
Degree of agreement30 daysAgreement between the internists AI-aided interpretation and the interpretation by expert cardiologist
Clinical significant findings detected by the internist utilizing AI-aided POCUS30 days

Secondary

MeasureTime frame
Percent of POCUS images of good quality30 days
Loops that AI interpreted30 days

Countries

Israel

Contacts

Primary ContactRobert Klempfner, MD
robert.klempfner@sheba.health.gov.il97235302362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026