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Clinical Trials/NCT05127460
NCT05127460CompletedNot Applicable

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

National Defense Medical Center, Taiwan2 sites in 1 country25,732 target enrollmentStarted: January 1, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
25,732
Locations
2
Primary Endpoint
Proportion of taking AF treatment medications
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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)

Outcomes

Primary Outcomes

Proportion of taking AF treatment medications

Time Frame: Within 90 days

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

Proportion of ischemic Stroke

Time Frame: Within 90 days

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

Secondary Outcomes

  • Proportion of hemorrhagic stroke(Within 90 days)
  • Proportion of all cause mortality(death)(Within 90 days)
  • Proportion of cardiologist consultation(Within 90 days)
  • Proportion of new-onset heart failure(Within 90 days)
  • Proportion of new-onset AF diagnosis(Within 90 days)
  • Proportion of echocardiogram performed after ECGs(Within 90 days)
  • Proportion of gastrointestinal bleeding(Within 90 days)

Investigators

Sponsor
National Defense Medical Center, Taiwan
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chin Lin

Assistant Professor

National Defense Medical Center, Taiwan

Study Sites (2)

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