NCT05455541

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
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Cardiovascular Diseases
• Valvular Heart Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-21
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-07-13
• Last updated: 2024-01-03

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study