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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis
• Intervention / Treatment: Device: ACE (AI-Cirrhosis-ECG) 2.0

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Minnesota
      • Contact: Douglas Simonetto; Phone Number: 507-284-1649; Email: dulcetrial@mayo.edu
      • Contact: Amy Olofson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Criteria:

Inclusion Criteria:

• Primary care clinicians (physicians, nurse practitioners, and physician assistants).
• Part of a team that cares for adult patients (≥18 years).
• Have the ability to order ECG.
• Consent will be obtained from primary care clinicians.
• Patients' data will be collected from electronic medical records (EMR).
• Adult patients (≥ 18 years) undergoing an ECG for any indication over a period of 6 months will be included.

Exclusion Criteria:

• Patients with known cirrhosis based on noninvasive fibrosis assessment tests, liver biopsy or complications of decompensated disease, or with a documented history of cirrhosis identified by clinical notes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Group; Primary care providers will treat subject per standard of care
Experimental: Electrocardiogram AI Group; The ACE (AI-Cirrhosis-ECG) 2.0 will be used to alert primary care providers to the likelihood of advanced liver disease with a recommendation for laboratory tests.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective of this pragmatic trial is to validate a deep learning-based artificial intelligence (AI) model for early detection of cirrhosis-associated signals on digitized ECG.	Number of participants with new diagnosis of advanced liver disease as assessed by a novel electrocardiogram-enabled convoluted neural network (CNN) compared to standard of care at 6 months.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary objective is to assess barriers for adoption of an AI-enabled algorithm for detection of liver disease in routine community clinical practice.	Number of participants to not complete the recommended testing according to the electrocardiogram-enabled CNN.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Douglas Simonetto, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 22-009726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No