Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)

June 20, 2023 updated by: Chin Lin, National Defense Medical Center, Taiwan
This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based supporting tool for improving the diagnosis and management of ST-elevation myocardial infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • National Defense Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Patients randomized to intervention will have access to the screening tool.
Other: AI-enabled ECG-based Screening Tool
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.
No Intervention: Control
Patients randomized to control will continue routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E2C (ECG to coronary angiography) time
Time Frame: Within 6 hours
Time from ECG to activation of coronary angiography for STEMI patients.
Within 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ejection fractrion
Time Frame: Within 3 days
Ejection fractrion primary percutaneous coronary intervention for STEMI patients.
Within 3 days
Length of hospitalization
Time Frame: Within 28 days
After performing an electrocardiogram, the length of hospitalization.
Within 28 days
Highest concentration of high-sensitivity cardiac troponin I
Time Frame: Within 3 days
After performing an electrocardiogram, the highest concentration of high-sensitivity cardiac troponin I was followed.
Within 3 days
Highest concentration of creatine kinase
Time Frame: Within 3 days
After performing an electrocardiogram, the highest concentration of creatine kinase was followed.
Within 3 days
Number of CAG event
Time Frame: Within 6 hours
Number of CAG event
Within 6 hours
E2B (ECG to primary percutaneous coronary intervention) time
Time Frame: Within 6 hours
Time from ECG to complete of primary percutaneous coronary intervention for STEMI patients.
Within 6 hours
D2B (Door to Balloon Time) time
Time Frame: Within 6 hours
Time from first medical contact to complete of primary percutaneous coronary intervention for STEMI patients in emergency department.
Within 6 hours
D2C (Door to coronary angiography) time
Time Frame: Within 6 hours
Time from first medical contact to activation of coronary angiography for STEMI patients in emergency department.
Within 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

May 31, 2023

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)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDMC2021003

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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