Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis

Cardiac Amyloidosis Clinical Trial

Official title:

Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis: Protocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05557162
• Other study ID #: 22-005311
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

Other:
• AI ECG Amyloid algorithm
Artificial intelligence enabled electrocardiogram screening tool used to identify the predictive model that best differentiates those at greatest risk for an amyloidosis diagnosis

Locations

Country	Name	City	State
United States	Mayo Clinic Health System	Eau Claire	Wisconsin
United States	Mayo Clinic Health System -NWWI-Cardiology	Eau Claire	Wisconsin
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	1 year
Secondary	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).	1 year
Secondary	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.	1 year

External Links

•   Mayo Clinic Clinical Trials