Status:
NOT_YET_RECRUITING
Screening Cardiometabolic Opportunities Using Transformative Echocardiography Artificial Intelligence (SCOUT Echo-AI)
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Stanford University
Massachusetts General Hospital
Conditions:
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 detectio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT07216859
Start Date
January 1 2026
End Date
November 1 2027
Last Update
November 17 2025
Active Locations (4)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90034
2
Stanford Healthcare
Palo Alto, California, United States, 94588
3
Kaiser Permanente
Pleasanton, California, United States, 94588
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114