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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06887699
Enrollment
212000
Registered
2025-03-20
Start date
2025-08-01
Completion date
2028-06-30
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence (AI), Cost-effectiveness Analysis, Electrocardiogram, OMI - Occlusion Myocardial Infarction

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.

Interventions

OTHERAI-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.

Sponsors

National Defense Medical Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 MeasureFrom 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

MeasureTime frameDescription
Door-to-Wire time less than 90 minutes48 hoursThe 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.
In-hospital all-cause Mortality Rate90-day followThe proportion of patients who die from any cause, regardless of the underlying condition, during hospitalization.
In-hospital cardiac death90-day followThe proportion of patients who die from cardiovascular-related causes during hospitalization.
Length of ICU90-day followComparison of length of ICU between the intervention and control groups.
Length of hospitalization90-day followComparison of length of hospitalization between the intervention and control groups.
Cardiovascular events90-day followComposite cardiovascular events (Non-fatal MI + Non-fatal stroke + CV Death) The rate of composite cardiovascular events within 90 days.
Non-fatal MI90-day followThe rate of non-fatal MI within 90-days.
Non-fatal stroke (Ischemic stroke + Hemorrhagic stroke)90-day followThe rate of non-fatal strokes (both ischemic and hemorrhagic) within 90-days.
Cardiac Death90-day followThe proportion of patients who die from cardiovascular-related causes within 90-days.
Ischemic stroke90-day followThe incidence of ischemic stroke.
Hemorrhagic stroke90-day followThe incidence of hemorrhagic stroke.
All-cause mortality90-day followThe proportion of patients who die from any cause within 90-days.
Coronary artery bypass grafting (CABG)90-day followThe rate of patients who undergo coronary artery bypass surgery (CABG) within 90-days following OMI treatment.
Heart failure admission90-day followThe rate of hospital admissions for heart failure within 90-days following OMI treatment.
Re-hospitalization (from any cause)90-day followThe rate of readmission to the hospital within 90-days of discharge.

Countries

Taiwan

Contacts

CONTACTChin Lin, PhD
xup6fup@mail.ndmctsgh.edu.tw+886-2-8792-3100
PRINCIPAL_INVESTIGATORChin Lin, PhD

National Defense Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026