Cardiac DiseaseSHAPENCT03705650
SHAPE:SeeingtheHeartwithAIPoweredEcho
A study testing Limited Echocardiogram in people with Cardiac Disease, run by Sara Guttas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Limited Echocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 6 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial, Central DuPage
Winfield, Illinois, 60190
About this study
Official title: SHAPE: Seeing the Heart With AI Powered Echo
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).
- Conditions
- Cardiac Disease
- Being tested
- Limited Echocardiogram
- Keywords
- Disease detection, Medicare aged patients, routine physical examination, primary care, limited echocardiogram
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited EchocardiogramDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Medicare Primary Care Provider (PCP) Patients | Experimental | 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. Receives: Diagnostic Test: Limited Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start10 Oct 2018
- Primary completion30 Mar 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Guttas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Sara Guttas, Caption Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705650
- Sponsor's protocol ID
- SHAPE01
- Acronym
- SHAPE
- Status last verified
- Mar 2020
- First submitted
- 8 Oct 2018
- Last updated
- 23 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHAPE: Seeing the Heart With AI Powered Echo
- ClinicalTrials.gov ID
- NCT03705650
- Acronym / sponsor ID
- SHAPE / SHAPE01
- Conditions
- Cardiac Disease
- Keywords
- Disease detection, Medicare aged patients, routine physical examination, primary care, limited echocardiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sara GuttasIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medicare Primary Care Provider (PCP) Patients | Experimental | Diagnostic Test: Limited EchocardiogramThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limited EchocardiogramSTUDY 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. | Diagnostic test | Medicare Primary Care Provider (PCP) Patients |
Primary outcome
% 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.
1 secondary outcome
Number of minutes for non-specialists to perform studies using EchoGPS experimental guidance software
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited Echocardiogram in people with Cardiac Disease, run by Sara Guttas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.