CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrial Fibrillation New Onset

Intervention / Treatment
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* Other: AI-enabled ECG-based Screening Tool


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients randomized to intervention will have access to the screening tool. | Other: AI-enabled ECG-based Screening Tool<br>* 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.<br>|
| No Intervention: Control<br>Patients randomized to control will continue routine practice. | |

What is the study measuring?
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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 |