NCT05557162

Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20,143 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Amyloidosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-19
• Primary completion: 2025-07-23
• Completion: 2025-07-23
• First posted: 2022-09-27
• Last updated: 2026-02-17

Locations

4 sites across 1 country: United States