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

Sheba Medical Center

Status: Enrolling

Conditions: Valvular Heart Disease; Cardiovascular Diseases

Treatments: Diagnostic Test: AI augmented POCUS examination

Study type: Observational

Funder types: Other

Identifiers

NCT05455541

SHEBA-22-9419-KR-CTIL

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Hospitalized patients with an indication for POCUS examination

Description:

Patient with an accepted indication for point of care echo study that are clinical stable.

Treatment:

Diagnostic Test: AI augmented POCUS examination