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NCT Number: NCT06887699

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Armed Forces General Hospital, Kaohsiung City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-ECG P4P program

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. In-hospital cardiac death

    Time frame: 90-day follow

    The proportion of patients who die from cardiovascular-related causes during hospitalization.

  4. Length of ICU

    Time frame: 90-day follow

    Comparison of length of ICU between the intervention and control groups.

  5. Length of hospitalization

    Time frame: 90-day follow

    Comparison of length of hospitalization between the intervention and control groups.

  6. 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.

  7. Non-fatal MI

    Time frame: 90-day follow

    The rate of non-fatal MI within 90-days.

  8. 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.

  9. Cardiac Death

    Time frame: 90-day follow

    The proportion of patients who die from cardiovascular-related causes within 90-days.

  10. Ischemic stroke

    Time frame: 90-day follow

    The incidence of ischemic stroke.

  11. Hemorrhagic stroke

    Time frame: 90-day follow

    The incidence of hemorrhagic stroke.

  12. All-cause mortality

    Time frame: 90-day follow

    The proportion of patients who die from any cause within 90-days.

  13. 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.

  14. Heart failure admission

    Time frame: 90-day follow

    The rate of hospital admissions for heart failure within 90-days following OMI treatment.

  15. Re-hospitalization (from any cause)

    Time frame: 90-day follow

    The rate of readmission to the hospital within 90-days of discharge.

Other outcomes

  1. 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.

  2. 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.

  3. Contrast-induced acute kidney injury

    Time frame: 90-day follow

    The number of patients who received a procedure with contrast-induced acute kidney injury.

  4. Procedure related mortality

    Time frame: 90-day follow

    The proportion of patients who die due to the procedure within 90 days.

  5. In-hospital major bleeding

    Time frame: 90-day follow

    The incidence of in-hospital major bleeding events occurring within 90-days of treatment.

  6. Major bleeding

    Time frame: 90-day follow

    The incidence of major bleeding events occurring within 90-days of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Chin Lin, PhD

CONTACT

[email protected]

+886-2-8792-3100 ext. 18574

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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