A Study to Detect Advanced Liver Disease Via AI-enabled Electrocardiogram
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 248 people enrolled
- Started
- 18 Apr 2023
- Ended
- 1 Sept 2025
- Type of study
- Interventional, 4 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- ACE (AI-Cirrhosis-ECG) 2.0
- Record updated
- 16 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Other criteria
- Criteria:
Where in United States
- Mayo Clinic MinnesotaRochester, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Group 1: Usual Care Group-CliniciansNo study treatment, for comparison
Primary care providers will treat subject per standard of care
- Group 2: Electrocardiogram AI Group-CliniciansTreatment being tested
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.
Treatment: ACE (AI-Cirrhosis-ECG) 2.0
- Group 3: Usual Care Group-PatientsNo study treatment, for comparison
Patients will receive standard of care
- Group 4: Electrocardiogram AI Group-PatientsTreatment being tested
Patients whose Clinician will be alerted by the ACE (AI-Cirrhosis-ECG) 2.0 to the likelihood of advanced liver disease with a recommendation for laboratory tests.
Treatment: ACE (AI-Cirrhosis-ECG) 2.0
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Early Detection of Advanced Liver Disease Via Artificial Intelligence-Enabled Electrocardiogram (Advance): A Pragmatic, Cluster-Randomized Clinical Trial
- Publications
- Record updated
- 16 October 2026