Back to resultsArtificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
Primary Purpose
Myocardial Infarction, Acute
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
AI-enabled ECG-based Screening Tool
Sponsored by
About this trial
This is an interventional screening trial for Myocardial Infarction, Acute
Eligibility Criteria
Inclusion Criteria:
- Patients in emergency department or inpatient department.
- Patients recieved at least 1 ECG examination.
Exclusion Criteria:
- Suspected myocardial infarction related disease suffering sudden death without cardiac catheterization validation.
- The patients recieved ECG at the period of inactive AI-ECG system.
Sites / Locations
- National Defense Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Patients randomized to intervention will have access to the screening tool.
Patients randomized to control will continue routine practice.
Outcomes
Primary Outcome Measures
E2C (ECG to coronary angiography) time
Time from ECG to activation of coronary angiography for STEMI patients.
Secondary Outcome Measures
E2B (ECG to primary percutaneous coronary intervention) time
Time from ECG to complete of primary percutaneous coronary intervention for STEMI patients.
D2B (Door to Balloon Time) time
Time from first medical contact to complete of primary percutaneous coronary intervention for STEMI patients in emergency department.
D2C (Door to coronary angiography) time
Time from first medical contact to activation of coronary angiography for STEMI patients in emergency department.
Ejection fractrion
Ejection fractrion primary percutaneous coronary intervention for STEMI patients.
Highest concentration of high-sensitivity cardiac troponin I
After performing an electrocardiogram, the highest concentration of high-sensitivity cardiac troponin I was followed.
Highest concentration of creatine kinase
After performing an electrocardiogram, the highest concentration of creatine kinase was followed.
Length of hospitalization
After performing an electrocardiogram, the length of hospitalization.
Number of CAG event
Number of CAG event
Full Information
NCT ID
NCT05118009
First Posted
November 1, 2021
Last Updated
June 20, 2023
Sponsor
National Defense Medical Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05118009
Brief Title
Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
Official Title
Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients randomized to intervention will have access to the screening tool.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomized to control will continue routine practice.
Intervention Type
Other
Intervention Name(s)
AI-enabled ECG-based Screening Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
E2C (ECG to coronary angiography) time
Description
Time from ECG to activation of coronary angiography for STEMI patients.
Time Frame
Within 6 hours
Secondary Outcome Measure Information:
Title
E2B (ECG to primary percutaneous coronary intervention) time
Description
Time from ECG to complete of primary percutaneous coronary intervention for STEMI patients.
Time Frame
Within 6 hours
Title
D2B (Door to Balloon Time) time
Description
Time from first medical contact to complete of primary percutaneous coronary intervention for STEMI patients in emergency department.
Time Frame
Within 6 hours
Title
D2C (Door to coronary angiography) time
Description
Time from first medical contact to activation of coronary angiography for STEMI patients in emergency department.
Time Frame
Within 6 hours
Title
Ejection fractrion
Description
Ejection fractrion primary percutaneous coronary intervention for STEMI patients.
Time Frame
Within 3 days
Title
Highest concentration of high-sensitivity cardiac troponin I
Description
After performing an electrocardiogram, the highest concentration of high-sensitivity cardiac troponin I was followed.
Time Frame
Within 3 days
Title
Highest concentration of creatine kinase
Description
After performing an electrocardiogram, the highest concentration of creatine kinase was followed.
Time Frame
Within 3 days
Title
Length of hospitalization
Description
After performing an electrocardiogram, the length of hospitalization.
Time Frame
Within 28 days
Title
Number of CAG event
Description
Number of CAG event
Time Frame
Within 6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Defense Medical Center
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
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