NCT05127460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,732

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

November 1, 2021

Last Update Submit

March 24, 2023

Conditions

Atrial Fibrillation New Onset

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Proportion of cardiologist consultation

    Within 90 days

  • Proportion of new-onset AF diagnosis

    Within 90 days

  • Proportion of echocardiogram performed after ECGs

    Within 90 days

  • Proportion of new-onset heart failure

    Within 90 days

  • Proportion of gastrointestinal bleeding

    Within 90 days

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Patients randomized to intervention will have access to the screening tool.

Other: AI-enabled ECG-based Screening Tool

Control

NO INTERVENTION

Patients randomized to control will continue routine practice.

Interventions

AI-enabled ECG-based Screening ToolOTHER

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Defense Medical Center

Taipei, 114, Taiwan

Location

Related Publications (1)

  • Liu WT, Lin C, Lee CC, Chang CH, Fang WH, Tsai DJ, Lin WY, Hung Y, Chen KC, Lee CH, Tsai TN, Lin WS, Hung YJ, Lin SH, Tsai CS, Lin CS. Artificial Intelligence-Enabled ECGs for Atrial Fibrillation Identification and Enhanced Oral Anticoagulant Adoption: A Pragmatic Randomized Clinical Trial. J Am Heart Assoc. 2025 Jul 15;14(14):e042106. doi: 10.1161/JAHA.125.042106. Epub 2025 Jul 3.

    PMID: 40611485DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 19, 2021

Study Start

January 1, 2022

Primary Completion

October 31, 2022

Study Completion

January 31, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)