ECG AI-Guided Screening for Low Ejection Fraction

Not Applicable

Completed

• Conditions: Asymptomatic Left Ventricular Systolic Dysfunction (Disorder); Heart Failure
• Interventions: Other: AI-enabled ECG-based Screening Tool

• Registration Number: NCT04000087
• Lead Sponsor: Mayo Clinic

Brief Summary

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-25
• Study Start: 2019-06-26
• Study First Posted: 2019-06-27
• Primary Completion: 2020-03-31
• Study Completion: 2020-11-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

• Primary care clinicians who are part of a participating care team that care for adult patients and have the ability to order ECG and TTE (this includes physicians, nurse practitioners, and physician assistants).

Exclusion Criteria

• Primary care clinicians working in pediatrics, acute care, nursing homes, and resident care teams.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	AI-enabled ECG-based Screening Tool	Care teams randomized to intervention will have access to the screening tool.

Primary Outcome Measures

Name	Time	Method
New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%)	Within 90 days	Ejection fraction obtained by echocardiography.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States