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Completed

NCT Number: NCT05118009

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Defense Medical Center

Taipei, 114, Taiwan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

AI-enabled ECG-based Screening Tool

Other

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 outcomes

  1. E2C (ECG to coronary angiography) time

    Time frame: Within 6 hours

    Time from ECG to activation of coronary angiography for STEMI patients.

Secondary outcomes

  1. E2B (ECG to primary percutaneous coronary intervention) time

    Time frame: Within 6 hours

    Time from ECG to complete of primary percutaneous coronary intervention for STEMI patients.

  2. D2B (Door to Balloon Time) time

    Time frame: Within 6 hours

    Time from first medical contact to complete of primary percutaneous coronary intervention for STEMI patients in emergency department.

  3. D2C (Door to coronary angiography) time

    Time frame: Within 6 hours

    Time from first medical contact to activation of coronary angiography for STEMI patients in emergency department.

  4. Ejection fractrion

    Time frame: Within 3 days

    Ejection fractrion primary percutaneous coronary intervention for STEMI patients.

  5. Highest concentration of high-sensitivity cardiac troponin I

    Time frame: Within 3 days

    After performing an electrocardiogram, the highest concentration of high-sensitivity cardiac troponin I was followed.

  6. Highest concentration of creatine kinase

    Time frame: Within 3 days

    After performing an electrocardiogram, the highest concentration of creatine kinase was followed.

  7. Length of hospitalization

    Time frame: Within 28 days

    After performing an electrocardiogram, the length of hospitalization.

  8. Number of CAG event

    Time frame: Within 6 hours

    Number of CAG event

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 11, 2021
Registry last updated
Jun 22, 2023

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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