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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Morality; Intensity Care
• Intervention / Treatment: Other: AI-enabled ECG-based Screening Tool

• Study Type: Interventional
• Enrollment (Actual): 15965
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • National defense medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Patients randomized to intervention will have access to the screening tool. Once the AI-ECG indicates high risk of mortality, a warning message would be immediately triggered and sent to the corresponding attending physicians. Notifications appear in the recipient's smartphone message system for the prompt attention. The message notified the physician that, "An ECG was received for patient X. An ECG indicates high risk of mortality. Please intensively attend to patient's conditions. If the physicians need to further identify the ECG, click on the following link to connect the ECG and the result of AI-ECG prediction." Of note, although we will actively send a warning message for high risk cases, the AI-ECG report for low risk cases still presented the degree of risk. Physicians can check the relative severity by access EHR for patients in the intervention group.	Other: AI-enabled ECG-based Screening Tool; 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.
NO_INTERVENTION: Control; Patients will continue routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality (death)	After performing an electrocardiogram, the patient's survival is tracked.	Within 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular cause mortality (death)	After performing an electrocardiogram, the patient's survival is tracked.	Within 90 days
Arrhythmia medication	After performing an electrocardiogram, the patient recieved related intervention.	Within 12 hours
Electrolyte examination	After performing an electrocardiogram, the patient recieved electrolyte examination	Within 3 days
Cadiac examination	After performing an electrocardiogram, the patient recieved cadiac examination	Within 3-7 days

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2021
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (ACTUAL): November 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: NDMC2021005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No