CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection

Atrial Fibrillation New Onset Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127460
• Other study ID #: NDMC2021002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2023
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25732
• Est. completion date: January 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Other:
• AI-enabled ECG-based Screening Tool
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.

Locations

Country	Name	City	State
Taiwan	National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of taking AF treatment medications	defined as use of long-term NOAC (apixaban, rivaroxaban, endoxaban, dabigatran).	Within 90 days
Primary	Proportion of ischemic Stroke	After performing an electrocardiogram, the patient's physical conditions is tracked.	Within 90 days
Secondary	Proportion of cardiologist consultation	Cardiovascular outpatient visit after discovering atrial fibrillation.	Within 90 days
Secondary	Proportion of new-onset AF diagnosis	Atrial fibrillation diagnosis in medical records	Within 90 days
Secondary	Proportion of echocardiogram performed after ECGs	After performing the ECG examination, perform the echocardiography examination.	Within 90 days
Secondary	Proportion of new-onset heart failure	After performing an electrocardiogram, the patient's medical record is tracked.	Within 90 days
Secondary	Proportion of gastrointestinal bleeding	After performing an electrocardiogram, the patient's medical record is tracked.	Within 90 days
Secondary	Proportion of hemorrhagic stroke	After performing an electrocardiogram, the patient's medical record is tracked.	Within 90 days
Secondary	Proportion of all cause mortality(death)	After performing an electrocardiogram, the patient's survival is tracked.	Within 90 days