CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection

Not Applicable

Completed

• Conditions: Atrial Fibrillation New Onset
• Interventions: Other: AI-enabled ECG-based Screening Tool

• Registration Number: NCT05127460
• Lead Sponsor: National Defense Medical Center, Taiwan

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 Atrial Fibrillation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-19
• Study Start: 2022-01-01
• Primary Completion: 2022-10-31
• Study Completion: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25732

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Defense Medical Center; 🇨🇳 Taipei, Taiwan