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

Study Overview
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Brief Summary
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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

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

Conditions
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Cardiovascular Diseases, Valvular Heart Disease

Intervention / Treatment
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* Diagnostic Test: AI augmented POCUS examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically indicated POCUS cardiac assessment as determined by the treating physicians for an accepted clinical indication Willing and able to provide consent for a short partial transthoracic POCCUS examinations No urgent or other compelling need for a comprehensive echo exam by the echo lab. Exclusion Criteria: Unstable clinical condition that does not permit any reasonable delay necessary to obtain consent and perform the POCCUS Severe thoracic deformation or thoracic wall infection or wound that does not permit an adequate echocardiographic examination Very poor or non-diagnostic echocardiographic imaging quality on prior echocardiography examinations. Patients after lung resection Patients unable lie in bed and undergo a standard echo study Participation in an interventional study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized patients with an indication for POCUS examination<br>Patient with an accepted indication for point of care echo study that are clinical stable. | Diagnostic Test: AI augmented POCUS examination<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of agreement | Agreement between the internists AI-aided interpretation and the interpretation by expert cardiologist | 30 days | 
| Clinical significant findings detected by the internist utilizing AI-aided POCUS |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of POCUS images of good quality |  | 30 days | 
| Loops that AI interpreted |  | 30 days |