Back to resultsArtificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis
Primary Purpose
Cardiac Amyloidosis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AI ECG Amyloid algorithm
Sponsored by
About this trial
This is an interventional screening trial for Cardiac Amyloidosis
Eligibility Criteria
INCLUSION
- Mayo Clinic cardiology or hematology providers who care for adult patients
- Mayo Clinic providers who consent to participate on this study
EXCLUSION
1. None
Sites / Locations
- Mayo Clinic Arizona
- Mayo Clinic in Arizona
- Mayo Clinic Florida
- Mayo Clinic in Rochester
- Mayo Clinic Rochester
- Mayo Clinic Health System -NWWI-Cardiology
- Mayo Clinic Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Notification of the AI ECG algorithm and the A3E scores
Usual Care
Arm Description
Provider-facing recommendation report that alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders
No alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders
Outcomes
Primary Outcome Measures
To determine if AI ECG algorithm and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosisProtocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY)
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
Secondary Outcome Measures
To determine if AI ECG and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosis intervention across different practice types (strata)
Performance of AI ECG intervention across cardiology and hematology practices and between community and tertiary facilities will be analyzed by measuring rates of cardiac amyloidosis diagnosis across these strata
To assess provider satisfaction with the AI ECG intervention
For a screening tool to be effective, it has to be user friendly. The providers randomized to the AI ECG intervention arm will be surveyed to understand their experience. This endpoint will be descriptive. Providers will answer a 6 question using a 5-point Likert scale (higher number is more favorable).
To assess differential costs between the intervention arm and the standard of care arm
Upon trial completion, the difference in clinical expenditures between the intervention and standard of care arms will be compared. To this end, the rates of test ordering will be counted and compared between the interventional arm and the standard of care arm. A cost will be assigned to each test to calculate expenditures per correct diagnosis. The test of interest will include: NT-proBNP, troponin, protein electrophoresis with isotyping, serum immunoglobulin free light chains, 24-hour urinary protein with immunofixation, cardiac magnetic resonance imaging, echocardiogram, technetium pyrophosphate nuclear cardiac scintigraphy , endomyocardial biopsy, and fat aspirate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05557162
Brief Title
Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis
Official Title
Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis: Protocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
This pragmatic trial will be the first study to prospectively evaluate the use of the AI ECG dashboard along with an augmented report in everyday practice. The findings will also guide future implementation strategies and inform the translation of many of the current and future AI algorithms into the clinical setting. The participants are the providers. Basic demographic information about the providers will be collected as well as their reactions to the trial based educational guidance supplied to them. Patient health information will be collected on their patients using a HIPPA waiver. There will be no patient contact.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Notification of the AI ECG algorithm and the A3E scores
Arm Type
Experimental
Arm Description
Provider-facing recommendation report that alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders
Intervention Type
Other
Intervention Name(s)
AI ECG Amyloid algorithm
Intervention Description
Artificial intelligence enabled electrocardiogram screening tool used to identify the predictive model that best differentiates those at greatest risk for an amyloidosis diagnosis
Primary Outcome Measure Information:
Title
To determine if AI ECG algorithm and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosisProtocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY)
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To determine if AI ECG and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosis intervention across different practice types (strata)
Description
Performance of AI ECG intervention across cardiology and hematology practices and between community and tertiary facilities will be analyzed by measuring rates of cardiac amyloidosis diagnosis across these strata
Time Frame
1 year
Title
To assess provider satisfaction with the AI ECG intervention
Description
For a screening tool to be effective, it has to be user friendly. The providers randomized to the AI ECG intervention arm will be surveyed to understand their experience. This endpoint will be descriptive. Providers will answer a 6 question using a 5-point Likert scale (higher number is more favorable).
Time Frame
1 year
Title
To assess differential costs between the intervention arm and the standard of care arm
Description
Upon trial completion, the difference in clinical expenditures between the intervention and standard of care arms will be compared. To this end, the rates of test ordering will be counted and compared between the interventional arm and the standard of care arm. A cost will be assigned to each test to calculate expenditures per correct diagnosis. The test of interest will include: NT-proBNP, troponin, protein electrophoresis with isotyping, serum immunoglobulin free light chains, 24-hour urinary protein with immunofixation, cardiac magnetic resonance imaging, echocardiogram, technetium pyrophosphate nuclear cardiac scintigraphy , endomyocardial biopsy, and fat aspirate.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mayo Clinic cardiology or hematology providers who care for adult patients
Mayo Clinic providers who consent to participate on this study
Exclusion Criteria:
- None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Dispenzieri, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mayo Clinic Health System -NWWI-Cardiology
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Mayo Clinic Health System
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54703
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis
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