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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455541
• Other study ID #: SHEBA-22-9419-KR-CTIL
• Status: Recruiting
• Start date: August 21, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Sheba Medical Center
• Contact: Robert Klempfner, MD
• Phone: 97235302362
• Email: robert.klempfner[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical 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 ).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Diagnostic Test:
• AI 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of agreement	Agreement between the internists AI-aided interpretation and the interpretation by expert cardiologist	30 days
Primary	Clinical significant findings detected by the internist utilizing AI-aided POCUS		30 days
Secondary	Percent of POCUS images of good quality		30 days
Secondary	Loops that AI interpreted		30 days