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

Not Applicable

Not yet recruiting

• Conditions: OMI - Occlusion Myocardial Infarction; Artificial Intelligence (AI); Electrocardiogram; Cost-effectiveness Analysis

• Registration Number: NCT06887699
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief Summary

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-24
• Study Start: 2025-04-01
• Primary Completion: 2028-03-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
D-to-W time (Door to Wire Time)	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.
Cost Outcome Measure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan