The Impact of Artificial Intelligence Electrocardiography on Occlusion Myocardial Infarction Management Under the Value-Based Payment System

April 6, 2026 updated by: Chin Lin, National Defense Medical Center, Taiwan

A Randomized Clinical Trial Investigating the Impact of Artificial Intelligence Electrocardiography on Occlusion Myocardial Infarction Management Under the Value-Based Payment System

This trial will prospectively evaluate the impact of integrating AI-ECG within the pay-for-performance program on improving the diagnosis, treatment, and clinical outcomes of occlusion myocardial infarction patients by promoting accurate and timely diagnoses through financial incentives.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators have developed an AI-ECG system that provides real-time notifications for patients with potential occlusion myocardial infarction. This AI algorithm is seamlessly integrated into the Hospital Information System, allowing for the automatic generation of reports whenever an ECG is performed. The purpose of this study is to evaluate the impact of AI-ECG on the timely diagnosis of STEMI, including patients' outcomes and healthcare costs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
      • Taipei, Taiwan, 114
        • Recruiting
        • Taipei Municipal Wanfang Hospital
        • Contact:
    • Taiwan
      • Kaohsiung City, Taiwan, Taiwan, 807
        • Recruiting
        • Kaohsiung Armed Forces General Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients in the emergency department
  • Patients received at least 1 ECG examination.

Exclusion Criteria:

  • The patients received ECG at the period of inactive AI-ECG system.
  • Patients with a history of coronary angiography within the past 3 days.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AI-ECG P4P program
AI-ECG-assisted detection of OMI within the P4P program. The AI-ECG system will conduct a real-time analysis of the ECG. When the system identifies potential OMI cases, it will immediately send short message service notifications to the on-duty cardiologists. This will enable the cardiologists to promptly review and confirm the diagnosis.
Other: AI-ECG P4P program
The AI-ECG system will conduct a real-time analysis of the ECG. When the system identifies potential OMI cases, it will immediately send short message service notifications to the on-duty cardiologists. This will enable the cardiologists to promptly review and confirm the diagnosis.
No Intervention: Standard of care
Potential OMI patients will be initially assessed by frontline physicians. If OMI is suspected, the frontline physicians will promptly notify the on-duty cardiologists, who will then review the case for confirmation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
D-to-W time (Door to Wire Time)
Time Frame: From the start of the emergency visit to the following 48 hours.
Door-to-wire time refers to the duration from a patient's arrival at the emergency department (ED) to the successful placement of a wire into the coronary artery during a primary percutaneous coronary intervention (PPCI) procedure.
From the start of the emergency visit to the following 48 hours.
Cost Outcome Measure
Time Frame: From the start of the emergency visit to 90 days post-discharge.
Total expenditures, from the start of the emergency visit to 90 days post-discharge (in USD), for comparison between the intervention and control groups, based on records from NHI (National Health Insurance) claims data.
From the start of the emergency visit to 90 days post-discharge.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Door-to-Wire time less than 90 minutes
Time Frame: 48 hours
The proportion of patients achieving a Door-to-Wire time of less than 90 minutes in the intervention group compared to the control group. The intervention and control groups' door-to-wire time will be compared. Door-to-wire time is defined as the duration from the first ECG to the successful placement of the wire during PPCI for OMI patients in the emergent department.
48 hours
In-hospital all-cause Mortality Rate
Time Frame: 90-day follow
The proportion of patients who die from any cause, regardless of the underlying condition, during hospitalization.
90-day follow
In-hospital cardiac death
Time Frame: 90-day follow
The proportion of patients who die from cardiovascular-related causes during hospitalization.
90-day follow
Length of ICU
Time Frame: 90-day follow
Comparison of length of ICU between the intervention and control groups.
90-day follow
Length of hospitalization
Time Frame: 90-day follow
Comparison of length of hospitalization between the intervention and control groups.
90-day follow
Cardiovascular events
Time Frame: 90-day follow
Composite cardiovascular events (Non-fatal MI + Non-fatal stroke + CV Death) The rate of composite cardiovascular events within 90 days.
90-day follow
Non-fatal MI
Time Frame: 90-day follow
The rate of non-fatal MI within 90-days.
90-day follow
Non-fatal stroke (Ischemic stroke + Hemorrhagic stroke)
Time Frame: 90-day follow
The rate of non-fatal strokes (both ischemic and hemorrhagic) within 90-days.
90-day follow
Cardiac Death
Time Frame: 90-day follow
The proportion of patients who die from cardiovascular-related causes within 90-days.
90-day follow
Ischemic stroke
Time Frame: 90-day follow
The incidence of ischemic stroke.
90-day follow
Hemorrhagic stroke
Time Frame: 90-day follow
The incidence of hemorrhagic stroke.
90-day follow
All-cause mortality
Time Frame: 90-day follow
The proportion of patients who die from any cause within 90-days.
90-day follow
Coronary artery bypass grafting (CABG)
Time Frame: 90-day follow
The rate of patients who undergo coronary artery bypass surgery (CABG) within 90-days following OMI treatment.
90-day follow
Heart failure admission
Time Frame: 90-day follow
The rate of hospital admissions for heart failure within 90-days following OMI treatment.
90-day follow
Re-hospitalization (from any cause)
Time Frame: 90-day follow
The rate of readmission to the hospital within 90-days of discharge.
90-day follow

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure related mortality
Time Frame: 90-day follow
The proportion of patients who die due to the procedure within 90 days.
90-day follow
In-hospital major bleeding
Time Frame: 90-day follow
The incidence of in-hospital major bleeding events occurring within 90-days of treatment.
90-day follow
Major bleeding
Time Frame: 90-day follow
The incidence of major bleeding events occurring within 90-days of treatment.
90-day follow
Emergent CAG without PCI
Time Frame: From the start of the emergency visit to the following 48 hours.
The number of patients who received emergent coronary angiograms without lesions need intervention.
From the start of the emergency visit to the following 48 hours.
Procedure related vascular complications
Time Frame: From the start of the emergency visit to the following 48 hours.
The number of patients who received a procedure with vascular complications.
From the start of the emergency visit to the following 48 hours.
Contrast-induced acute kidney injury
Time Frame: 90-day follow
The number of patients who received a procedure with contrast-induced acute kidney injury.
90-day follow

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Defense Medical Center, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chin Lin, PhD, National Defense Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A202505035

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

product manufactured in and exported from the U.S.

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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