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OpenTrials
Completed

NCT Number: NCT03705650

SHAPE:SeeingtheHeartwithAIPoweredEcho

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).

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial, Central DuPage

Winfield, Illinois, 60190, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Limited Echocardiogram

Diagnostic Test

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.

Primary outcomes

  1. % 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

    Time frame: 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 outcomes

  1. Number of minutes for non-specialists to perform studies using EchoGPS experimental guidance software

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sara Guttas

Industry

Registry information

Official study title

SHAPE: Seeing the Heart With AI Powered Echo

Acronym: SHAPE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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