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Not yet recruitingNCT07216859SCOUT Echo-AIUpdated Aug 13, 2026

Screening Cardiometabolic Opportunities Using Transformative Echocardiography Artificial Intelligence (SCOUT Echo-AI)

An interventional study of AI-Enabled Identification (EchoNet-Liver) in MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Cirrhosis, sponsored by Kaiser Permanente. Not yet recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this prospective, multicenter, open-label, blinded end-point pragmatic study is to evaluate an artificial intelligence (AI)-augmented echocardiography screening approach for early detection of metabolic dysfunction associated steatotic liver disease (MASLD) and/or cirrhosis, in patients undergoing routine transthoracic echocardiograms (TTEs).

The main question it aims to answer is to:

  1. Evaluate notification responsiveness and rates of confirmatory testing for patients identified as high risk for having liver disease to determine whether optimized notifications increase timely confirmatory testing and treatment initiation versus standard of care assessment.
  2. Compare time to diagnosis, treatment uptake, and clinical outcomes (hospitalizations, incident ASCVD, mortality) between cohorts identified as high risk by the AI algorithm and comparison groups to determine whether AI guided screening shortens time to diagnosis and increases appropriate treatment.
02

Conditions studied

  • MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Cirrhosis

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03

In context

Fibrosis

1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 63 across 840 interventional studies indexed under Fibrosis.

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Lead sponsor

Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults ≥18 years.
  • Underwent routine TTE within site defined recent timeframe and flagged as high risk for MASLD and/or cirrhosis by the AI model using pre specified threshold.
  • Able to provide ; reachable for follow up.

Exclusion criteria

Exclusion Criteria:

  • Inability to consent or communicate.
  • Enrollment in hospice or so limited that additional evaluation would not be appropriate per clinician judgment.
  • Clinical circumstances where immediate alternative diagnostic pathways supersede study procedures (e.g., acute decompensation requiring urgent management).
  • Prior liver or kidney transplant.
  • Patient unwilling to undergo prospective testing for liver disease.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    AI Notification (EchoNet-Liver-Flagged patients)

    Participants whose prior transthoracic echocardiograms are flagged by an AI model (EchoNet-Liver) as high risk for MASLD and/or cirrhosis, a notification is delivered to the primary treating clinician, or undergoes a structured diagnostic workflow for standard of care at their site.

    Other: AI-Enabled Identification (EchoNet-Liver)

Interventions

  • OtherAI-Enabled Identification (EchoNet-Liver)

    AI-generated notifications to clinicians about possible undiagnosed liver disease (MASLD and/or Cirrhosis) detected from Transthoracic Echocardiogram

06

What researchers measure

Primary outcomes

  1. Positive Predictive Value (PPV) of the AI algorithm for detecting MASLD and/or cirrhosis confirmed within 12 months of AI identification.

    Numerator: Participants with clinician-confirmed diagnosis of later stage MASLD and/or cirrhosis after confirmatory evaluation. Denominator: * Participants with positive AI screen who were enrolled and evaluated. * The intervention is the clinician referral or referral testing workflow. The clinicians ultimately have discretion to avoid further downstream testing if pretest probability is felt to be too low. If a clinician determines no further testing is warranted despite high risk assessment by AI, the participant will be classified as a false positive (still counted in the denominator).

    Time frame: From enrollment to end of follow up at 1 year.

Secondary outcomes

  1. Time to diagnosis of MASLD/cirrhosis

    Time (days) from AI identification to first confirmatory diagnosis

    Time frame: Followed up to 24 months post notification.

  2. Time to diagnosis for MASLD with F2 fibrosis or greater

    Time (days) from AI identification to first confirmatory diagnosis

    Time frame: Followed up to 24 months post notification.

  3. Time to diagnosis for steatotic liver disease

    Time (days) from AI identification to first confirmatory diagnosis

    Time frame: Followed up to 24 months post notification.

  4. Time to confirmatory imaging

    Time (days) from AI identification

    Time frame: Followed up to 24 months post notification.

  5. Time to initiation of targeted treatment

    Time (days) from AI identification

    Time frame: Followed up to 24 months post notification.

  6. All-cause mortality

    Time (days) from AI identification

    Time frame: Followed up to 24 months post notification.

  7. All-cause hospitalization

    Time (days) from AI identification

    Time frame: Followed up to 24 months post notification.

  8. Heart failure hospitalization

    Time (days) from AI identification (Defined as admission with IV diuretics or elevated BNP)

    Time frame: Followed up to 24 months post notification.

  9. Cardiovascular hospitalization

    Time (days) from AI identification for Cardiovascular hospitalization (defined by principal ICD9/10 code)

    Time frame: Followed up to 24 months post notification.

  10. Hepatic decompensation hospitalization

    Time (days) from AI identification for hepatic decompensation hospitalization (defined by ascites, hepatic encephalopathy, variceal bleeding, hepatocellular carcinoma, or liver transplantation)

    Time frame: Followed up to 24 months post notification.

  11. New ASCVD diagnosis

    Time (days) from AI identification

    Time frame: Followed up to 24 months post notification.

07

Study locations

6 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2028; primary completion for Nov 2028, 10 months later.

Of 186 non-industry interventional studies with no phase under Fibrosis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 52. This study's planned 10 months is below that.

Counting every sponsor, half of 194 studies reached it within 32 months; a quarter within 18 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2025
First posted
Oct 15, 2025
StartEst.
Jan 1, 2028
Primary completionEst.
Nov 1, 2028
CompletionEst.
Nov 1, 2028
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07216859
Lead sponsor
Kaiser Permanente
Collaborators
Stanford University, Massachusetts General Hospital, Cedars-Sinai Medical Center
Responsible party
David Ouyang (Int Med-Cardio Non-Invasive, Kaiser Permanente) — Principal investigator
First posted
Oct 15, 2025
Start date
Jan 1, 2028 (estimated)
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Aug 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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