Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis
3 other identifiers
interventional
20,143
1 country
4
Brief Summary
The purpose of this study is to assess a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of cardiac amyloidosis (CA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 27, 2022
CompletedStudy Start
First participant enrolled
June 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2025
CompletedFebruary 17, 2026
February 1, 2026
2.1 years
September 16, 2022
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To determine if AI ECG algorithm and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosis
The number of patients diagnosed with cardiac amyloidosis in cardiology and hematology practices will be compared between those providers undergoing the AI ECG intervention to those randomized to standard practice arm
1 year
Secondary Outcomes (3)
To determine if AI ECG and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosis intervention across different practice types (strata)
1 year
To assess provider satisfaction with the AI ECG intervention
1 year
To assess differential costs between the intervention arm and the standard of care arm
1 year
Study Arms (2)
Notification of the AI ECG algorithm and the A3E scores
EXPERIMENTALProvider-facing recommendation report that alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders
Usual Care
NO INTERVENTIONNo alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders
Interventions
Artificial intelligence enabled electrocardiogram screening tool used to identify the predictive model that best differentiates those at greatest risk for an amyloidosis diagnosis
Eligibility Criteria
You may qualify if:
- Mayo Clinic cardiology or hematology providers who care for adult patients
- Mayo Clinic providers who consent to participate on this study
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (4)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54701, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Dispenzieri, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 27, 2022
Study Start
June 19, 2023
Primary Completion
July 23, 2025
Study Completion
July 23, 2025
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share