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

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: Recruiting
• Conditions: Electrocardiogram; Cost-effectiveness Analysis; Artificial Intelligence (AI); OMI - Occlusion Myocardial Infarction
• Intervention / Treatment: Other: AI-ECG P4P program

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: Interventional
• Enrollment (Estimated): 212000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin Lin, PhD; Phone Number: 18574 +886-2-8792-3100; Email: xup6fup@mail.ndmctsgh.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Recruiting
    • Tri-Service General Hospital
    • Contact: Yuan-Hao Chen, PhD; Phone Number: +886287923311; Email: chenyh178@gmail.com
  • Taipei, Taiwan, 114
    • Recruiting
    • Taipei Municipal Wanfang Hospital
    • Contact: CHIN LIN; Phone Number: 0958259269; Email: xup6fup0629@gmail.com
  • Taiwan
    • Kaohsiung City, Taiwan, Taiwan, 807
      • Recruiting
      • Kaohsiung Armed Forces General Hospital
      • Contact: CHIN LIN; Phone Number: 0958259269; Email: xup6fup0629@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
D-to-W time (Door to Wire Time)	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	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

Outcome Measure	Measure Description	Time Frame
Door-to-Wire time less than 90 minutes	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	The proportion of patients who die from any cause, regardless of the underlying condition, during hospitalization.	90-day follow
In-hospital cardiac death	The proportion of patients who die from cardiovascular-related causes during hospitalization.	90-day follow
Length of ICU	Comparison of length of ICU between the intervention and control groups.	90-day follow
Length of hospitalization	Comparison of length of hospitalization between the intervention and control groups.	90-day follow
Cardiovascular events	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	The rate of non-fatal MI within 90-days.	90-day follow
Non-fatal stroke (Ischemic stroke + Hemorrhagic stroke)	The rate of non-fatal strokes (both ischemic and hemorrhagic) within 90-days.	90-day follow
Cardiac Death	The proportion of patients who die from cardiovascular-related causes within 90-days.	90-day follow
Ischemic stroke	The incidence of ischemic stroke.	90-day follow
Hemorrhagic stroke	The incidence of hemorrhagic stroke.	90-day follow
All-cause mortality	The proportion of patients who die from any cause within 90-days.	90-day follow
Coronary artery bypass grafting (CABG)	The rate of patients who undergo coronary artery bypass surgery (CABG) within 90-days following OMI treatment.	90-day follow
Heart failure admission	The rate of hospital admissions for heart failure within 90-days following OMI treatment.	90-day follow
Re-hospitalization (from any cause)	The rate of readmission to the hospital within 90-days of discharge.	90-day follow

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure related mortality	The proportion of patients who die due to the procedure within 90 days.	90-day follow
In-hospital major bleeding	The incidence of in-hospital major bleeding events occurring within 90-days of treatment.	90-day follow
Major bleeding	The incidence of major bleeding events occurring within 90-days of treatment.	90-day follow
Emergent CAG without PCI	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	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	The number of patients who received a procedure with contrast-induced acute kidney injury.	90-day follow

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Investigators: Principal Investigator: Chin Lin, PhD, National defense medical center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction
• Other Study ID 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