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

Not Applicable

Not yet recruiting

• Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Cirrhosis

• Registration Number: NCT07216859
• Lead Sponsor: Kaiser Permanente

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-13
• Study First Submitted QC: 2025-10-14
• Last Update Submitted: 2025-10-14
• Study First Posted: 2025-10-15
• Last Update Posted: 2025-10-15
• Study Start: 2025-11-01
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Positive Predictive Value (PPV) of the AI algorithm for detecting MASLD and/or cirrhosis confirmed within 12 months of AI identification.	From enrollment to end of follow up at 1 year.	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).

Secondary Outcome Measures

Name	Time	Method
Time to diagnosis of MASLD/cirrhosis	Followed up to 24 months post notification.	Time (days) from AI identification to first confirmatory diagnosis
Time to diagnosis for MASLD with F2 fibrosis or greater	Followed up to 24 months post notification.	Time (days) from AI identification to first confirmatory diagnosis
Time to diagnosis for steatotic liver disease	Followed up to 24 months post notification.	Time (days) from AI identification to first confirmatory diagnosis
Time to confirmatory imaging	Followed up to 24 months post notification.	Time (days) from AI identification
Time to initiation of targeted treatment	Followed up to 24 months post notification.	Time (days) from AI identification
All-cause mortality	Followed up to 24 months post notification.	Time (days) from AI identification
All-cause hospitalization	Followed up to 24 months post notification.	Time (days) from AI identification
Heart failure hospitalization	Followed up to 24 months post notification.	Time (days) from AI identification (Defined as admission with IV diuretics or elevated BNP)
Cardiovascular hospitalization	Followed up to 24 months post notification.	Time (days) from AI identification for Cardiovascular hospitalization (defined by principal ICD9/10 code)
Hepatic decompensation hospitalization	Followed up to 24 months post notification.	Time (days) from AI identification for hepatic decompensation hospitalization (defined by ascites, hepatic encephalopathy, variceal bleeding, hepatocellular carcinoma, or liver transplantation)
New ASCVD diagnosis	Followed up to 24 months post notification.	Time (days) from AI identification

Trial Locations

Locations (4)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford Healthcare; 🇺🇸 Palo Alto, California, United States

Kaiser Permanente; 🇺🇸 Pleasanton, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States