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Not yet recruiting NCT07216859

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

No phase Interventional MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-Enabled Identification (EchoNet-Liver).
Who it may be relevant to
Registry conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other AI-Enabled Identification (EchoNet-Liver)
    AI-generated notifications to clinicians about possible undiagnosed liver disease (MASLD and/or Cirrhosis) detected from Transthoracic Echocardiogram

Primary outcome measures

  • Positive Predictive Value (PPV) of the AI algorithm for detecting MASLD and/or cirrhosis confirmed within 12 months of AI identification. [Time frame: From enrollment to end of follow up at 1 year.]
Secondary outcome measures (11)
  • Time to diagnosis of MASLD/cirrhosis [Time frame: Followed up to 24 months post notification.]
  • Time to diagnosis for MASLD with F2 fibrosis or greater [Time frame: Followed up to 24 months post notification.]
  • Time to diagnosis for steatotic liver disease [Time frame: Followed up to 24 months post notification.]
  • Time to confirmatory imaging [Time frame: Followed up to 24 months post notification.]
  • Time to initiation of targeted treatment [Time frame: Followed up to 24 months post notification.]
  • All-cause mortality [Time frame: Followed up to 24 months post notification.]
  • All-cause hospitalization [Time frame: Followed up to 24 months post notification.]
  • Heart failure hospitalization [Time frame: Followed up to 24 months post notification.]
  • Cardiovascular hospitalization [Time frame: Followed up to 24 months post notification.]
  • Hepatic decompensation hospitalization [Time frame: Followed up to 24 months post notification.]
  • New ASCVD diagnosis [Time frame: Followed up to 24 months post notification.]

Eligibility criteria

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 informed consent; reachable for follow up.

Exclusion criteria

  • Inability to consent or communicate.
  • Enrollment in hospice or life expectancy 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 4 centers
  • Cedars-Sinai Medical Center — Los Angeles
  • Stanford Healthcare — Palo Alto
  • Kaiser Permanente — Pleasanton
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07216859 · 2356334 · 25AHAAI1487693

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗