SHAPE:SeeingtheHeartwithAIPoweredEcho

Sara Guttas

Status: Completed

Conditions: Cardiac Disease

Treatments: Diagnostic Test: Limited Echocardiogram

Study type: Interventional

Funder types: Industry

Identifiers

NCT03705650

SHAPE01

Details and patient eligibility

About

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).

Enrollment: 55 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients indicated for a standard physical examination
2. Patients ≥65 years old

For patients in Phase I, one of the following additional inclusion criteria must be present:

1. Patient presenting with a new murmur, or history of a murmur but no prior echo within 3 years of the exam
2. Patient presenting with shortness of breath
3. Unexplained pedal edema

Exclusion criteria

1. Unable to lie flat for study
2. Significant anatomical abnormality, recent trauma, or recent thoracic/abdominal surgery that would limit the ability to obtain adequate images
3. Subjects unwilling or unable to give written informed consent
4. 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Medicare Primary Care Provider (PCP) Patients

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Limited Echocardiogram