CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection

Computer-assisted Atrial Fibrillation Risk Detection In Oral-anticoagulant Use, Lowering Stroke Risk, and Optimizing Guidance With an Intelligent Screening Tool (CARDIOLOGIST): a Pragmatic Randomized Controlled Trial

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 Atrial Fibrillation.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation New Onset
• Intervention / Treatment: Other: AI-enabled ECG-based Screening Tool

• Study Type: Interventional
• Enrollment (Actual): 25732
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • National Defense Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients in emergency department or inpatient department
• Patients had at least 1 ECG
• Patients cared by non-cardiologist

Exclusion Criteria:

• Patients without history of atrial fibrillation diagnosis.
• Patients without history of long-term NOAC or warfarin usage.
• Patients without history of hemorrhagic stoke or ishemic stroke.
• Patients with low eGFR (<30 ml/min)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients randomized to intervention will have access to the screening tool.	Other: AI-enabled ECG-based Screening Tool; Primary care clinicians in the intervention group had access to the report, which displayed whether the AI-ECG result was positive or negative. The system will send a message to corresponding physicians if positive finding.
No Intervention: Control; Patients randomized to control will continue routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of taking AF treatment medications	defined as use of long-term NOAC (apixaban, rivaroxaban, endoxaban, dabigatran).	Within 90 days
Proportion of ischemic Stroke	After performing an electrocardiogram, the patient's physical conditions is tracked.	Within 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of cardiologist consultation	Cardiovascular outpatient visit after discovering atrial fibrillation.	Within 90 days
Proportion of new-onset AF diagnosis	Atrial fibrillation diagnosis in medical records	Within 90 days
Proportion of echocardiogram performed after ECGs	After performing the ECG examination, perform the echocardiography examination.	Within 90 days
Proportion of new-onset heart failure	After performing an electrocardiogram, the patient's medical record is tracked.	Within 90 days
Proportion of gastrointestinal bleeding	After performing an electrocardiogram, the patient's medical record is tracked.	Within 90 days
Proportion of hemorrhagic stroke	After performing an electrocardiogram, the patient's medical record is tracked.	Within 90 days
Proportion of all cause mortality(death)	After performing an electrocardiogram, the patient's survival is tracked.	Within 90 days

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NDMC2021002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No