Back to resultsCARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection
Primary Purpose
Atrial Fibrillation New Onset
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
AI-enabled ECG-based Screening Tool
Sponsored by
About this trial
This is an interventional screening trial for Atrial Fibrillation New Onset
Eligibility Criteria
Inclusion Criteria:
- Patients without Atrial Fibrillation (AF) diagnosis.
Exclusion Criteria:
- Patients with stroke history.
Sites / Locations
- National Defense Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Patients randomized to intervention will have access to the screening tool.
Patients randomized to control will continue routine practice.
Outcomes
Primary Outcome Measures
Proportion of taking AF treatment medications
defined as use of long-term NOAC (apixaban, rivaroxaban, endoxaban, dabigatran).
Proportion of ischemic Stroke
After performing an electrocardiogram, the patient's physical conditions is tracked.
Secondary Outcome Measures
Proportion of cardiologist consultation
Cardiovascular outpatient visit after discovering atrial fibrillation.
Proportion of new-onset AF diagnosis
Atrial fibrillation diagnosis in medical records
Proportion of echocardiogram performed after ECGs
After performing the ECG examination, perform the echocardiography examination.
Proportion of new-onset heart failure
After performing an electrocardiogram, the patient's medical record is tracked.
Proportion of gastrointestinal bleeding
After performing an electrocardiogram, the patient's medical record is tracked.
Proportion of hemorrhagic stroke
After performing an electrocardiogram, the patient's medical record is tracked.
Proportion of all cause mortality(death)
After performing an electrocardiogram, the patient's survival is tracked.
Full Information
NCT ID
NCT05127460
First Posted
November 1, 2021
Last Updated
March 24, 2023
Sponsor
National Defense Medical Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05127460
Brief Title
CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation New Onset
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25732 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients randomized to intervention will have access to the screening tool.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomized to control will continue routine practice.
Intervention Type
Other
Intervention Name(s)
AI-enabled ECG-based Screening Tool
Intervention Description
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 Outcome Measure Information:
Title
Proportion of taking AF treatment medications
Description
defined as use of long-term NOAC (apixaban, rivaroxaban, endoxaban, dabigatran).
Time Frame
Within 90 days
Title
Proportion of ischemic Stroke
Description
After performing an electrocardiogram, the patient's physical conditions is tracked.
Time Frame
Within 90 days
Secondary Outcome Measure Information:
Title
Proportion of cardiologist consultation
Description
Cardiovascular outpatient visit after discovering atrial fibrillation.
Time Frame
Within 90 days
Title
Proportion of new-onset AF diagnosis
Description
Atrial fibrillation diagnosis in medical records
Time Frame
Within 90 days
Title
Proportion of echocardiogram performed after ECGs
Description
After performing the ECG examination, perform the echocardiography examination.
Time Frame
Within 90 days
Title
Proportion of new-onset heart failure
Description
After performing an electrocardiogram, the patient's medical record is tracked.
Time Frame
Within 90 days
Title
Proportion of gastrointestinal bleeding
Description
After performing an electrocardiogram, the patient's medical record is tracked.
Time Frame
Within 90 days
Title
Proportion of hemorrhagic stroke
Description
After performing an electrocardiogram, the patient's medical record is tracked.
Time Frame
Within 90 days
Title
Proportion of all cause mortality(death)
Description
After performing an electrocardiogram, the patient's survival is tracked.
Time Frame
Within 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
National Defense Medical Center
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection
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