Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)

Study Overview
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Brief Summary
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This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based supporting tool for improving the diagnosis and management of ST-elevation myocardial infarction.

Official Title
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Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)

Conditions
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Myocardial Infarction, Acute

Intervention / Treatment
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* Other: AI-enabled ECG-based Screening Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in emergency department or inpatient department. Patients recieved at least 1 ECG examination. Exclusion Criteria: The patients recieved ECG at the period of inactive AI-ECG system.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients randomized to intervention will have access to the screening tool. | Other: AI-enabled ECG-based Screening Tool<br>* Primary care clinicians in the intervention group had access to the report, which displayed whether the AI-ECG result was positive or negative.The system will send a message to corresponding physicians if positive finding.<br>|
| No Intervention: Control<br>Patients randomized to control will continue routine practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E2C (ECG to coronary angiography) time | Time from ECG to activation of coronary angiography for STEMI patients. | Within 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E2B (ECG to primary percutaneous coronary intervention) time | Time from ECG to complete of primary percutaneous coronary intervention for STEMI patients. | Within 6 hours | 
| D2B (Door to Balloon Time) time | Time from first medical contact to complete of primary percutaneous coronary intervention for STEMI patients in emergency department. | Within 6 hours | 
| D2C (Door to coronary angiography) time | Time from first medical contact to activation of coronary angiography for STEMI patients in emergency department. | Within 6 hours | 
| Ejection fractrion | Ejection fractrion primary percutaneous coronary intervention for STEMI patients. | Within 3 days | 
| Highest concentration of high-sensitivity cardiac troponin I | After performing an electrocardiogram, the highest concentration of high-sensitivity cardiac troponin I was followed. | Within 3 days | 
| Highest concentration of creatine kinase | After performing an electrocardiogram, the highest concentration of creatine kinase was followed. | Within 3 days | 
| Length of hospitalization | After performing an electrocardiogram, the length of hospitalization. | Within 28 days | 
| Number of CAG event | Number of CAG event | Within 6 hours |