SHAPE:SeeingtheHeartwithAIPoweredEcho

Study Overview
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Brief Summary
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Establish transthoracic echocardiogram (TTE) exams performed with Bay Labs EchoGPS guidance technology can be used in a primary care setting to accurately identify cardiac disease. In Phase I TTE exams with EchoGPS will be compared to findings from a commercially available, FDA 510(k)-cleared reference device (Terason uSmart 3200t, point-of-care ultrasound) without EchoGPS assistance technology. Study is non-significant risk (NSR).

Official Title
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SHAPE: Seeing the Heart With AI Powered Echo

Conditions
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Cardiac Disease

Intervention / Treatment
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* Diagnostic Test: Limited Echocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients indicated for a standard physical examination Patients ≥65 years old For patients in Phase I, one of the following additional inclusion criteria must be present: Patient presenting with a new murmur, or history of a murmur but no prior echo within 3 years of the exam Patient presenting with shortness of breath Unexplained pedal edema Exclusion Criteria: Unable to lie flat for study Significant anatomical abnormality, recent trauma, or recent thoracic/abdominal surgery that would limit the ability to obtain adequate images Subjects unwilling or unable to give written informed consent Patients experiencing a known or suspected acute cardiac event Eligibility criteria for Phases II and III of this study will be finalized once results from Phase I are available. The current plan is to have similar criteria for Phases II and III.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medicare Primary Care Provider (PCP) Patients<br>This is a non-randomized study of non-significant risk (NSR) that will be conducted at Northwestern's Central Dupage Hospital. Medicare patients > 65 years who are scheduled for a routine physical exam with their PCP that meet inclusion and exclusion criteria will be asked to participate in this study. Consenting patients will be scheduled for 2 back to back ultrasound scans including 5 standard 2D echocardiogram views each. The first scan will be performed by a non-ultrasound specialist using EchoGPS experimental guidance technology and the second control exam will be performed by a trained sonographer using a cleared conventional ultrasound platform. | Diagnostic Test: Limited Echocardiogram<br>* STUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance, feedback and interpretation assistance to users during image acquisition. For this study, CMAs will use EchoGPS to perform point-of-care echocardiogram examinations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of diagnostic quality clips acquired by a non-specialist using experimental guidance software, with quality assessed using the American College of Emergency Physician (ACEP) Suggested Quality Assurance Grading Scale | All of the echo views (or clips) acquired by non-specialists during the study will be scored for image quality (IQ) by clinicians using the 1-5 ACEP quality grading scale. In this scale, a score of 1 represents the poorest IQ and 5 the highest. Images must have a score of 3 or higher to be considered diagnostic quality. Diagnostic quality images (3+) meet at least minimal criteria for diagnosis to be supported and are therefore clinically acceptable. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of minutes for non-specialists to perform studies using EchoGPS experimental guidance software | Number of minutes for non-specialists to perform studies using EchoGPS software as compared to that of the time for expert sonographer's control studies using FDA 510(k)-cleared, commercially available ultrasound platform. The time of Study Exam will be compared to that of Control Exam on a per subject basis (paired difference) for Phase I of the study. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disease detection, Medicare aged patients, routine physical examination, primary care, limited echocardiogram