Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis

Mayo Clinic

Status: Active, not recruiting

Conditions: Cardiac Amyloidosis

Treatments: Other: AI ECG Amyloid algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT05557162

PREDICT-AMY (Other Identifier)

NCI-2024-00928 (Registry Identifier)

22-005311

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20,143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20,143 participants in 2 patient groups

Notification of the AI ECG algorithm and the A3E scores

Experimental group

Description:

Provider-facing recommendation report that alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders

Treatment:

Other: AI ECG Amyloid algorithm

Usual Care

No Intervention group

Description:

No alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders