Skip to main content
OpenTrials
Completed

NCT Number: NCT05127460

CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation New Onset

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Defense Medical Center

Taipei, 114, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AI-enabled ECG-based Screening Tool

Other

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.

Primary outcomes

  1. Proportion of taking AF treatment medications

    Time frame: Within 90 days

    defined as use of long-term NOAC (apixaban, rivaroxaban, endoxaban, dabigatran).

  2. Proportion of ischemic Stroke

    Time frame: Within 90 days

    After performing an electrocardiogram, the patient's physical conditions is tracked.

Secondary outcomes

  1. Proportion of cardiologist consultation

    Time frame: Within 90 days

    Cardiovascular outpatient visit after discovering atrial fibrillation.

  2. Proportion of new-onset AF diagnosis

    Time frame: Within 90 days

    Atrial fibrillation diagnosis in medical records

  3. Proportion of echocardiogram performed after ECGs

    Time frame: Within 90 days

    After performing the ECG examination, perform the echocardiography examination.

  4. Proportion of new-onset heart failure

    Time frame: Within 90 days

    After performing an electrocardiogram, the patient's medical record is tracked.

  5. Proportion of gastrointestinal bleeding

    Time frame: Within 90 days

    After performing an electrocardiogram, the patient's medical record is tracked.

  6. Proportion of hemorrhagic stroke

    Time frame: Within 90 days

    After performing an electrocardiogram, the patient's medical record is tracked.

  7. Proportion of all cause mortality(death)

    Time frame: Within 90 days

    After performing an electrocardiogram, the patient's survival is tracked.

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 19, 2021
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.