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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-21

Study Completion Date

2023-12-31

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

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Detailed Description

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Conditions

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Cardiovascular Diseases Valvular Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospitalized patients with an indication for POCUS examination

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

AI augmented POCUS examination

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No