Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05127460
Enrollment
25732
Registered
2021-11-19
Start date
2022-01-01
Completion date
2023-01-31
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation New Onset

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.

Interventions

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.

Sponsors

National Defense Medical Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of ischemic StrokeWithin 90 daysAfter performing an electrocardiogram, the patient's physical conditions is tracked.
Proportion of taking AF treatment medicationsWithin 90 daysdefined as use of long-term NOAC (apixaban, rivaroxaban, endoxaban, dabigatran).

Secondary

MeasureTime frameDescription
Proportion of echocardiogram performed after ECGsWithin 90 daysAfter performing the ECG examination, perform the echocardiography examination.
Proportion of new-onset heart failureWithin 90 daysAfter performing an electrocardiogram, the patient's medical record is tracked.
Proportion of cardiologist consultationWithin 90 daysCardiovascular outpatient visit after discovering atrial fibrillation.
Proportion of hemorrhagic strokeWithin 90 daysAfter performing an electrocardiogram, the patient's medical record is tracked.
Proportion of all cause mortality(death)Within 90 daysAfter performing an electrocardiogram, the patient's survival is tracked.
Proportion of gastrointestinal bleedingWithin 90 daysAfter performing an electrocardiogram, the patient's medical record is tracked.
Proportion of new-onset AF diagnosisWithin 90 daysAtrial fibrillation diagnosis in medical records

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026