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Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms

Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05117970
Enrollment
13631
Registered
2021-11-11
Start date
2021-12-09
Completion date
2023-12-31
Last updated
2024-10-23

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

Conditions

Left Ventricular Systolic Dysfunction (Disorder)

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 left ventricular systolic dysfunction.

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
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with EF\>50% or without Transesophageal Echocardiography (TEE)

Exclusion criteria

* Patients with a history of heart failure or an EF\<= 35%.

Design outcomes

Primary

MeasureTime frameDescription
New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤50%)Within 30 daysEjection fraction obtained by echocardiography

Secondary

MeasureTime frameDescription
All cause mortality(death)Within 30 daysAfter performing an electrocardiogram, the patient's survival is tracked.
Completion of an echocardiogramWithin 30 daysAfter performing the ECG examination, perform the echocardiogram examination

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026