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Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality

Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality: a Pragmatic Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05118035
Enrollment
15965
Registered
2021-11-11
Start date
2021-12-15
Completion date
2022-12-31
Last updated
2023-02-08

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

Conditions

Cardiovascular Diseases, Intensity Care, Morality

Brief summary

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for early detection of clinical deterioration for reducing mortality.

Interventions

Primary care clinicians in the intervention group had access to the report, which shows the risk prediction results for each patients. Moreover, the clinicians will recieve a short message when patients with a high risk ECG identified by AI.

Sponsors

National Defense Medical Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Intervention model description

intervention group:8001 control group:7964

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients in emergency department or inpatient department. * Patients recieved at least 1 ECG examination.

Exclusion criteria

* The patients recieved ECG at the period of inactive AI-ECG system.

Design outcomes

Primary

MeasureTime frameDescription
All cause mortality (death)Within 90 daysAfter performing an electrocardiogram, the patient's survival is tracked.

Secondary

MeasureTime frameDescription
Cardiovascular cause mortality (death)Within 90 daysAfter performing an electrocardiogram, the patient's survival is tracked.
Arrhythmia medicationWithin 12 hoursAfter performing an electrocardiogram, the patient recieved related intervention.
Electrolyte examinationWithin 3 daysAfter performing an electrocardiogram, the patient recieved electrolyte examination
Cadiac examinationWithin 3-7 daysAfter performing an electrocardiogram, the patient recieved cadiac examination

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026