Clinical trial NCT06887699: The Impact of Artificial Intelligence Electrocardiography on Occlusion Myocardial Infarction Management Under the Value-Based Payment System
Official title: A Randomized Clinical Trial Investigating the Impact of Artificial Intelligence Electrocardiography on Occlusion Myocardial Infarction Management Under the Value-Based Payment System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: OMI - Occlusion Myocardial Infarction
Artificial Intelligence (AI)
Electrocardiogram
Cost-effectiveness Analysis
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 212000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: D-to-W time (Door to Wire Time)
timeFrame: From the start of the emergency visit to the following 48 hours.
measure: Cost Outcome Measure
timeFrame: From the start of the emergency visit to 90 days post-discharge.
Secondary outcomes:
measure: Door-to-Wire time less than 90 minutes
timeFrame: 48 hours
measure: In-hospital all-cause Mortality Rate
timeFrame: 90-day follow
measure: In-hospital cardiac death
timeFrame: 90-day follow
measure: Length of ICU
timeFrame: 90-day follow
measure: Length of hospitalization
timeFrame: 90-day follow
measure: Cardiovascular events
timeFrame: 90-day follow
measure: Non-fatal MI
timeFrame: 90-day follow
measure: Non-fatal stroke (Ischemic stroke + Hemorrhagic stroke)
timeFrame: 90-day follow
measure: Cardiac Death
timeFrame: 90-day follow
measure: Ischemic stroke
timeFrame: 90-day follow
measure: Hemorrhagic stroke
timeFrame: 90-day follow
measure: All-cause mortality
timeFrame: 90-day follow
measure: Coronary artery bypass grafting (CABG)
timeFrame: 90-day follow
measure: Heart failure admission
timeFrame: 90-day follow
measure: Re-hospitalization (from any cause)
timeFrame: 90-day follow
Other outcomes:
measure: Emergent CAG without PCI
timeFrame: From the start of the emergency visit to the following 48 hours.
measure: Procedure related vascular complications
timeFrame: From the start of the emergency visit to the following 48 hours.
measure: Contrast-induced acute kidney injury
timeFrame: 90-day follow
measure: Procedure related mortality
timeFrame: 90-day follow
measure: In-hospital major bleeding
timeFrame: 90-day follow
measure: Major bleeding
timeFrame: 90-day follow
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: National Defense Medical Center
name: Chin Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: