Echocardiography, TransthoracicAI INSIGHTNCT07229300
AI ECHO INSIGHT RCT for Automated Echo Reporting
A study testing AI-Assisted Echocardiogram Interpretation, Sonographer-Assisted Echocardiogram Interpretation and Cardiologist-Only Echocardiogram Interpretation in people with Echocardiography, Transthoracic and Echocardiographic Software, run by Kaiser Permanente at 1 site in United States.
Trial summary
The goal of this blinded randomized controlled trial is to assess whether AI-assisted TTE interpretation can improve cardiologist efficiency and reduce interpretation variability while preserving accuracy compared to current methods in adult patients whose historical echocardiogram images were performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Transthoracic, Echocardiographic Software
- What is being tested?
- AI-Assisted Echocardiogram Interpretation, Sonographer-Assisted Echocardiogram Interpretation and Cardiologist-Only Echocardiogram Interpretation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Comprehensive transthoracic echocardiogram study performed a KPNC Medical Center.
Who cannot join
- Known Congenital heart disease study
- Known Ventricular assist device
- Limited transthoracic echocardiogram study
- Transesophageal echocardiogram study
- Stress echocardiogram study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Northern California Division of Research
Pleasanton, California, 94588
About this study
Official title: Artificial Intelligence Echocardiogram Interpretation for Systematic Integration and Guided Healthcare Transformation (The AI ECHO INSIGHT Study)
The goal of this blinded randomized controlled trial is to assess whether AI-assisted TTE interpretation can improve cardiologist efficiency and reduce interpretation variability while preserving accuracy compared to current methods in adult patients whose historical echocardiogram images were performed.
The main questions it aims to answer is to:
- Assess overall transthoracic echocardiogram (TTE) interpretation accuracy of an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to hypothesize if AI-assisted workflow for echocardiography interpretation is non-inferior in accuracy compared to standard workflows.
- Evaluate cardiologist interpretation time using an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to determine if an AI-assisted workflow will result in a decrease in interpretation time compared to the cardiologist-only workflow.
- To compare interpretation consistency and reliability compared to historical reports as well as consensus reports of all finalized cardiologist reports.
- Being tested
- AI-Assisted Echocardiogram Interpretation, Sonographer-Assisted Echocardiogram Interpretation, Cardiologist-Only Echocardiogram Interpretation
- Keywords
- Echocardiography Interpretation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Echocardiogram InterpretationOther
Echocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist.
Sonographer-Assisted Echocardiogram InterpretationOther
(Standard of Care 1): Echocardiogram studies are pre-interpreted by a sonographer and finalized by a blinded cardiologist.
Cardiologist-Only Echocardiogram InterpretationOther
(Standard of Care 2): Echocardiogram studies are interpreted solely by two cardiologists (one provides a preliminary interpretation another provides a blinded final interpretation).
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Interpretation | Active comparator | In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist. Receives: Other: AI-Assisted Echocardiogram Interpretation |
| Sonographer-Assisted Interpretation | Active comparator | In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist. Receives: Other: Sonographer-Assisted Echocardiogram Interpretation |
| Cardiologist-Only Interpretation | Active comparator | In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist. Receives: Other: Cardiologist-Only Echocardiogram Interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows.
The accuracy rate is defined as the proportion of transthoracic echocardiogram (TTE) studies for which the final cardiologist interpretation is not significantly different from the preliminary interpretation. We will assess the accuracy rate in the AI-assisted arm for non-inferiority versus the pooled accuracy rate across both the sonographer-assisted and cardiologist-only arms.
The investigators will measure the proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
Measured: 6 months
Secondary outcomes (7)
Secondary Measures of Accuracy (Superiority Analyses)
Accuracy rates will also be analyzed for superiority rather than non-inferiority. The proportion of TTE studies for which the final cardiologist interpretation is not significantly different from the preliminary interpretation will be compared individually between the AI-assisted arm and each comparator arm (sonographer-assisted and cardiologist-only).
- AI-prelim workflow vs. pooled sonographer-prelim and cardiologist-prelim workflow with a superiority test
- AI-prelim workflow vs. sonographer-prelim workflow with a superiority test
- AI-prelim workflow vs. cardiologist-prelim workflow with a superiority test
Measured: 6 months
Accuracy Compared with Historical Cardiologist Interpretations
Accuracy is defined as the proportion of TTE studies for which the final cardiologist report is substantially different from the historical report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
Measured: 6 months
Accuracy Compared with Consensus Cardiologist Interpretations
Accuracy is defined as the proportion of TTE studies for which the consensus cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
Measured: 6 months
Evaluation requiring two-grade change in valve disease severity as substantial change
Accuracy is defined asthe proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventricular function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
- AI-prelim workflow vs. pooled sonographer-prelim and cardiologist-prelim workflow with a superiority test
- AI-prelim workflow vs. sonographer-prelim workflow with a superiority test
- AI-prelim workflow vs. cardiologist-prelim workflow with a superiority test
Measured: 6 months
Cardiologist Overread Time (Efficiency)
To assess whether AI-assisted interpretation saves time, the investigators will compare the mean time in seconds required for the cardiologist to complete the overreading process across the three arms (i.e., TTE interpretation workflows) in our trial. Specifically, we will perform the following comparisons:
- The mean cardiologist overread time in the AI-assisted arm versus the pooled results of the sonographer-assisted and cardiologist-only arms
- The mean cardiologist overread time in the AI-assisted arm versus the sonographer-assisted arm
- The mean cardiologist overread time in the AI-assisted arm versus the cardiologist-only arm
Measured: 6 months
Comparison of Existing Standards of Care (Sonographer-Assisted vs Cardiologist-Only)
The investigators will measure the proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change) in sonographer-prelim and cardiologist-prelim arms. We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventricular function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
Measured: 6 months
Blinding
In each of the arms, at the completion of each study for the final cardiologist assessment, the cardiologist will be asked to guess whether the preliminary assessment was AI or human. This will be used to calculate a blinding index comparing the AI-prelim arm vs. a composite of the two standard of care arms, as well as comparing the AI-prelim arm with the sonographer-prelim arm individually and comparing the AI-prelim arm with the cardiologist-prelim arm individually.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start1 Nov 2025
- Primary completion1 Aug 2026
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Echocardiography, TransthoracicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ouyang, Kaiser Permanente
- Investigators
- Keane K Lee, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229300
- Sponsor's protocol ID
- 2302504
- Acronym
- AI INSIGHT
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lee KK, Kumar N, Eusuff S, Vukadinovic M, Ieki H, Moore MJ, Ambrosy AP, Go AS, Jang J, Dinh H, Ku IA, Liu V, Ouyang D, Claggett B, He B. AI echo INSIGHT study: A prospective blinded randomized trial of artificial intelligence echocardiogram interpretation. Contemp Clin Trials. 2026 Aug 9:108431. doi: 10.1016/j.cct.2026.108431. Online ahead of print.
PubMed 42571809
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Echocardiogram Interpretation for Systematic Integration and Guided Healthcare Transformation (The AI ECHO INSIGHT Study)
- ClinicalTrials.gov ID
- NCT07229300
- Acronym / sponsor ID
- AI INSIGHT / 2302504
- Keywords
- Echocardiography Interpretation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 14 Nov 2025 (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.
The goal of this blinded randomized controlled trial is to assess whether AI-assisted TTE interpretation can improve cardiologist efficiency and reduce interpretation variability while preserving accuracy compared to current methods in adult patients whose historical echocardiogram images were performed.
The main questions it aims to answer is to:
- Assess overall transthoracic echocardiogram (TTE) interpretation accuracy of an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to hypothesize if AI-assisted workflow for echocardiography interpretation is non-inferior in accuracy compared to standard workflows.
- Evaluate cardiologist interpretation time using an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to determine if an AI-assisted workflow will result in a decrease in interpretation time compared to the cardiologist-only workflow.
- To compare interpretation consistency and reliability compared to historical reports as well as consensus reports of all finalized cardiologist reports.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Interpretation | Active comparator | Other: AI-Assisted Echocardiogram InterpretationIn AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist. |
| Sonographer-Assisted Interpretation | Active comparator | Other: Sonographer-Assisted Echocardiogram InterpretationIn Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist. |
| Cardiologist-Only Interpretation | Active comparator | Other: Cardiologist-Only Echocardiogram InterpretationIn cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- Comprehensive transthoracic echocardiogram study performed a KPNC Medical Center.
Key exclusion criteria (5 listed)
- Known Congenital heart disease study
- Known Ventricular assist device
- Limited transthoracic echocardiogram study
- Transesophageal echocardiogram study
- Stress echocardiogram study
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 |
|---|---|---|
| AI-Assisted Echocardiogram InterpretationEchocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist. | Other | AI-Assisted Interpretation |
| Sonographer-Assisted Echocardiogram Interpretation(Standard of Care 1): Echocardiogram studies are pre-interpreted by a sonographer and finalized by a blinded cardiologist. | Other | Sonographer-Assisted Interpretation |
| Cardiologist-Only Echocardiogram Interpretation(Standard of Care 2): Echocardiogram studies are interpreted solely by two cardiologists (one provides a preliminary interpretation another provides a blinded final interpretation). | Other | Cardiologist-Only Interpretation |
Primary outcome
Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows.
Time frame: 6 months
The accuracy rate is defined as the proportion of transthoracic echocardiogram (TTE) studies for which the final cardiologist interpretation is not significantly different from the preliminary interpretation. We will assess the accuracy rate in the AI-assisted arm for non-inferiority versus the pooled accuracy rate across both the sonographer-assisted and cardiologist-only arms. The investigators will measure the proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
7 secondary outcomes
Secondary Measures of Accuracy (Superiority Analyses)
Time frame: 6 months
Accuracy Compared with Historical Cardiologist Interpretations
Time frame: 6 months
Accuracy Compared with Consensus Cardiologist Interpretations
Time frame: 6 months
Evaluation requiring two-grade change in valve disease severity as substantial change
Time frame: 6 months
Cardiologist Overread Time (Efficiency)
Time frame: 6 months
Comparison of Existing Standards of Care (Sonographer-Assisted vs Cardiologist-Only)
Time frame: 6 months
Blinding
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 42571809Lee KK, Kumar N, Eusuff S, Vukadinovic M, Ieki H, Moore MJ, Ambrosy AP, Go AS, Jang J, Dinh H, Ku IA, Liu V, Ouyang D, Claggett B, He B. AI echo INSIGHT study: A prospective blinded randomized trial of artificial intelligence echocardiogram interpretation. Contemp Clin Trials. 2026 Aug 9:108431. doi: 10.1016/j.cct.2026.108431. Online ahead of print.
- Individual participant dataSharing planned: Yes
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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.
Keane K Lee principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Echocardiogram Interpretation, Sonographer-Assisted Echocardiogram Interpretation and Cardiologist-Only Echocardiogram Interpretation in people with Echocardiography, Transthoracic and Echocardiographic Software, run by Kaiser Permanente 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 2 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229300, which also lists 1 linked publication.
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 6 Aug 2026.