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

Myocardial Infarction, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118009
• Other study ID #: NDMC2021003
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43176
• Est. completion date: May 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute
• ST Elevation Myocardial Infarction

Intervention

Other:
• AI-enabled ECG-based Screening Tool
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.

Locations

Country	Name	City	State
Taiwan	National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	E2C (ECG to coronary angiography) time	Time from ECG to activation of coronary angiography for STEMI patients.	Within 6 hours
Secondary	E2B (ECG to primary percutaneous coronary intervention) time	Time from ECG to complete of primary percutaneous coronary intervention for STEMI patients.	Within 6 hours
Secondary	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
Secondary	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
Secondary	Ejection fractrion	Ejection fractrion primary percutaneous coronary intervention for STEMI patients.	Within 3 days
Secondary	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
Secondary	Highest concentration of creatine kinase	After performing an electrocardiogram, the highest concentration of creatine kinase was followed.	Within 3 days
Secondary	Length of hospitalization	After performing an electrocardiogram, the length of hospitalization.	Within 28 days
Secondary	Number of CAG event	Number of CAG event	Within 6 hours