About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AI-Enabled Identification (EchoNet-Liver)
Treatment groups
Sponsors and collaborators
Kaiser Permanente
Lead sponsor
Stanford University
Collaborator
Massachusetts General Hospital
Collaborator
Cedars-Sinai Medical Center
Collaborator