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

NCT05782283 | Completed FDA Device

• 1 other identifier: 22-009726
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary objective is to assess barriers for adoption of an AI-enabled algorithm for detection of liver disease in routine community clinical practice.

  6 months

Study Arms (2)

Usual Care Group

NO INTERVENTION

Primary care providers will treat subject per standard of care

Electrocardiogram AI Group

EXPERIMENTAL

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

Interventions

ACE (AI-Cirrhosis-ECG) 2.0 DEVICE

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.

Electrocardiogram AI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Simonetto DA, Rushlow D, Liu K, Calleri A, Kassmeyer BA, Lennon RJ, Rattan P, Bernard ME, Singh G, Deyo-Svendsen ME, King G, Stacey SK, Olofson A, Allen A, Ahn JC, Friedman PA, Kamath PS, Attia ZI, Noseworthy PA, Shah VH. Detection of undiagnosed liver cirrhosis via AI-enabled electrocardiogram: a pragmatic, cluster-randomized clinical trial. Nat Med. 2025 Dec 17. doi: 10.1038/s41591-025-04058-y. Online ahead of print.

  PMID: 41408416 DERIVED

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas Simonetto, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 23, 2023
• Study Start: April 18, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)