CirrhosisADVANCENCT05782283

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

A study testing ACE (AI-Cirrhosis-ECG) 2.0 in people with Cirrhosis, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cirrhosis
What is being tested?: ACE (AI-Cirrhosis-ECG) 2.0
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 248 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2023to 1 Sep 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Minnesota
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

Read the 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
Being tested: ACE (AI-Cirrhosis-ECG) 2.0
Medical subject headings: Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACE (AI-Cirrhosis-ECG) 2.0Device
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.

Study groups in NCT05782283
Study group	Role	What they receive
Group 1: Usual Care Group-Clinicians	No intervention	Primary care providers will treat subject per standard of care
Group 2: Electrocardiogram AI Group-Clinicians	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. Receives: Device: ACE (AI-Cirrhosis-ECG) 2.0
Group 3: Usual Care Group-Patients	No intervention	Patients will receive standard of care
Group 4: Electrocardiogram AI Group-Patients	Experimental	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. Receives: Device: ACE (AI-Cirrhosis-ECG) 2.0

What is being measured

The primary outcome is the main question the study is designed to answer.

New Diagnosis of Advanced Chronic Liver Disease
The primary objective of this pragmatic trial is to validate a deep learning-based machine learning (ML) model for early detection of cirrhosis-associated signals on digitized ECG. The primary outcome is the 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.
Measured: 6 months

Secondary outcomes (1)

Number of Participants to Not Complete Recommended Testing
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 20231 Sep 2025

First posted23 Mar 2023
Study start18 Apr 2023
Primary completion1 Sep 2025
Study completion1 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CirrhosisStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05782283
Sponsor's protocol ID: 22-009726
Acronym: ADVANCE
Status last verified: Aug 2026
First submitted: 8 Feb 2023
Last updated: 16 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Calleri A, Yazarkan Y, Liu K, Kassmeyer BA, Lennon RJ, Rattan P, Seid A, 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, Rushlow D, Simonetto DA. Clinician engagement shapes the impact of AI-based ECG screening for chronic liver disease in primary care. NPJ Digit Med. 2026 May 9;9(1):553. doi: 10.1038/s41746-026-02718-y.
PubMed 42106573
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. 2026 Jan;32(1):160-167. doi: 10.1038/s41591-025-04058-y. Epub 2025 Dec 17.
PubMed 41408416

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Detection of Advanced Liver Disease Via Artificial Intelligence-Enabled Electrocardiogram (Advance): A Pragmatic, Cluster-Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05782283
Acronym / sponsor ID: ADVANCE / 22-009726
Conditions: Cirrhosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 18 Apr 2023 (actual)
Primary completion: 1 Sep 2025 (actual)
Study completion: 1 Sep 2025 (actual)
First posted: 23 Mar 2023 (actual)
Results: Posted 16 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1: Usual Care Group-Clinicians	No intervention	–Primary care providers will treat subject per standard of care
Group 2: Electrocardiogram AI Group-Clinicians	Experimental	Device: ACE (AI-Cirrhosis-ECG) 2.0The 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.
Group 3: Usual Care Group-Patients	No intervention	–Patients will receive standard of care
Group 4: Electrocardiogram AI Group-Patients	Experimental	Device: ACE (AI-Cirrhosis-ECG) 2.0Patients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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).

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACE (AI-Cirrhosis-ECG) 2.0An 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.	Device	Group 2: Electrocardiogram AI Group-Clinicians, Group 4: Electrocardiogram AI Group-Patients

Primary outcome

New Diagnosis of Advanced Chronic Liver Disease
Time frame: 6 months
The primary objective of this pragmatic trial is to validate a deep learning-based machine learning (ML) model for early detection of cirrhosis-associated signals on digitized ECG. The primary outcome is the 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.

1 secondary outcome

Number of Participants to Not Complete Recommended Testing
Time frame: 6 months

Results and safety

Results posted to the registry on 16 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Usual Care Group-Clinician	122	122
Group 2: Electrocardiogram Machine Learning Group-Clinican	126	123
Group 3: Usual Care Group-Patients	7,562	7,562
Group 4: Electrocardiogram Machine Learning Group-Patients	8,034	8,034

Primary outcome: New Diagnosis of Advanced Chronic Liver Disease

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Usual Care Group n = 7562	Electrocardiogram Machine Learning Group n = 8034
Value	35	78

Population analysed: The trial consented and enrolled clinicians caring for adult patients in primary care. The analysis was conducted on the patients of enrolled clinicians, hence the discrepancy in number of enrolled vs analyzed populations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were not monitored or assessed for any clinician or patient.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Group 1: Usual Care Group-Clinicians	0 of 0	0 of 0
Group 2: Electrocardiogram Machine Learning Group-Clinicians	0 of 0	0 of 0
Group 3: Usual Care Group-Patients	0 of 0	0 of 0
Group 4: Electrocardiogram Machine Learning Group-Patients	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42106573Calleri A, Yazarkan Y, Liu K, Kassmeyer BA, Lennon RJ, Rattan P, Seid A, 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, Rushlow D, Simonetto DA. Clinician engagement shapes the impact of AI-based ECG screening for chronic liver disease in primary care. NPJ Digit Med. 2026 May 9;9(1):553. doi: 10.1038/s41746-026-02718-y.
Derived from this study: PubMed 41408416Simonetto 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. 2026 Jan;32(1):160-167. doi: 10.1038/s41591-025-04058-y. Epub 2025 Dec 17.
Individual participant dataSharing planned: No

Related trials for Cirrhosis

Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas Simonetto, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ACE (AI-Cirrhosis-ECG) 2.0 in people with Cirrhosis, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New Diagnosis of Advanced Chronic Liver Disease (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05782283, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.