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Artificial Intelligence

AI-Enabled ECG for Liver Disease (ADVANCE Trial)

N/A
Waitlist Available
Led By Douglas Simonetto, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if an AI-enabled algorithm can accurately detect liver disease early & if it's accepted in primary care.

Who is the study for?
This trial is for adults who are getting an ECG test and whose doctors can order such tests. It's aimed at those in primary care settings, including physicians, nurse practitioners, and physician assistants who agree to participate. People with known advanced liver disease or a history of cirrhosis are not eligible.
What is being tested?
The study is testing the ACE (AI-Cirrhosis-ECG) 2.0 model to see if it can effectively detect early signs of severe liver fibrosis using AI analysis of ECG results. The goal is also to assess how well this AI tool is accepted in a primary care environment.
What are the potential side effects?
Since the intervention involves non-invasive ECG monitoring and data analysis through an AI algorithm, there are no direct physical side effects associated with the trial itself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
The secondary objective is to assess barriers for adoption of an AI-enabled algorithm for detection of liver disease in routine community clinical practice.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Electrocardiogram AI GroupExperimental Treatment1 Intervention
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.
Group II: Usual Care GroupActive Control1 Intervention
Primary care providers will treat subject per standard of care

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,061,745 Total Patients Enrolled
19 Trials studying Liver Cirrhosis
6,474 Patients Enrolled for Liver Cirrhosis
Douglas Simonetto, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

ACE 2.0 (Artificial Intelligence) Clinical Trial Eligibility Overview. Trial Name: NCT05782283 — N/A
Liver Cirrhosis Research Study Groups: Usual Care Group, Electrocardiogram AI Group
Liver Cirrhosis Clinical Trial 2023: ACE 2.0 Highlights & Side Effects. Trial Name: NCT05782283 — N/A
ACE 2.0 (Artificial Intelligence) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05782283 — N/A
~119 spots leftby Aug 2025