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

NCT05782283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2025-09-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Douglas Simonetto, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2025-09-01
Completion
2025-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05782283 on ClinicalTrials.gov