NCT05782283

A Study to Detect Advanced Liver Disease Via AI-enabled Electrocardiogram

Early Detection of Advanced Liver Disease Via Artificial Intelligence-Enabled Electrocardiogram (Advance): A Pragmatic, Cluster-Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objectives of this study are to determine the effectiveness of ACE 2.0 model in early detection of advanced liver fibrosis, and to determine the acceptance and barriers for use of an AI-enabled algorithm for prediction of liver disease in primary care.

Detailed description

A pragmatic, cluster randomized trial in 45 Mayo Clinic primary care practices will be conducted over a period of 6 months with 6 months of follow up. Care teams will be randomized 1:1 to intervention or usual care, stratified by region and patient volume. In the intervention arm, the DULCE score will be used to alert consenting providers to the likelihood of advanced liver disease with a recommendation for a FibroTest-ActiTest. The primary endpoint will be detection of advanced liver disease. Secondary outcomes will include completion of noninvasive fibrosis assessment tests and hepatology referral within 180 days of ECG, new diagnosis of liver disease stratified by etiology (nonalcoholic fatty liver disease, alcohol-associated liver disease, hepatitis C, and others) and severity (compensated with and without clinically-significant portal hypertension, and decompensated disease), initiation of prophylactic nonselective beta-blockers and imaging for hepatocellular carcinoma surveillance, according to published society guidelines. Post-study surveys to participating clinicians will be applied.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DEVICE	ACE (AI-Cirrhosis-ECG) 2.0	An electrocardiogram (ECG) based artificial intelligence (AI) powered tool for detection of undiagnosed cirrhosis in primary care practices. And email alert is sent to providers which will display whether the ACE 2.0 result is positive or negative for the likelihood of advanced liver disease.

Timeline

• Start date: 2023-04-18
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-03-23
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study