SHAPE:SeeingtheHeartwithAIPoweredEcho
- Conditions
- Cardiac Disease
- Interventions
- Diagnostic Test: Limited Echocardiogram
- Registration Number
- NCT03705650
- Lead Sponsor
- Sara Guttas
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medicare Primary Care Provider (PCP) Patients Limited Echocardiogram 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.
- Primary Outcome Measures
Name Time Method % 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 1 year 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.
- Secondary Outcome Measures
Name Time Method Number of minutes for non-specialists to perform studies using EchoGPS experimental guidance software 1 year 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.
Trial Locations
- Locations (1)
Northwestern Memorial, Central DuPage
🇺🇸Winfield, Illinois, United States