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

Recruiting

• Conditions: Cardiovascular Diseases; Valvular Heart Disease
• Interventions: Diagnostic Test: AI augmented POCUS examination

• Registration Number: NCT05455541
• Lead Sponsor: Sheba Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-13
• Study Start: 2022-08-21
• Status Verified: 2023-10
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Last Update Submitted: 2023-12-30
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized patients with an indication for POCUS examination	AI augmented POCUS examination	Patient with an accepted indication for point of care echo study that are clinical stable.

Primary Outcome Measures

Name	Time	Method
Degree of agreement	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	30 days

Secondary Outcome Measures

Name	Time	Method
Percent of POCUS images of good quality	30 days
Loops that AI interpreted	30 days

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel