Myocardial Infarction, AcuteNCT05118009
Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
A study testing AI-enabled ECG-based Screening Tool in people with Myocardial Infarction, Acute, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute
- What is being tested?
- AI-enabled ECG-based Screening Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43,176 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in emergency department or inpatient department.
- Patients recieved at least 1 ECG examination.
Who cannot join
- The patients recieved ECG at the period of inactive AI-ECG system.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myocardial Infarction, Acute
- Being tested
- AI-enabled ECG-based Screening Tool
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled ECG-based Screening ToolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized to intervention will have access to the screening tool. Receives: Other: AI-enabled ECG-based Screening Tool |
| Control | No intervention | Patients randomized to control will continue routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
E2C (ECG to coronary angiography) time
Time from ECG to activation of coronary angiography for STEMI patients.
Measured: Within 6 hours
Secondary outcomes (8)
E2B (ECG to primary percutaneous coronary intervention) time
Time from ECG to complete of primary percutaneous coronary intervention for STEMI patients.
Measured: 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.
Measured: 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.
Measured: Within 6 hours
Ejection fractrion
Ejection fractrion primary percutaneous coronary intervention for STEMI patients.
Measured: 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.
Measured: Within 3 days
Highest concentration of creatine kinase
After performing an electrocardiogram, the highest concentration of creatine kinase was followed.
Measured: Within 3 days
Length of hospitalization
After performing an electrocardiogram, the length of hospitalization.
Measured: Within 28 days
Number of CAG event
Number of CAG event
Measured: Within 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 May 2022
- Primary completion30 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Lin, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118009
- Sponsor's protocol ID
- NDMC2021003
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin C, Liu WT, Chang CH, Lee CC, Hsing SC, Fang WH, Tsai DJ, Chen KC, Lee CH, Cheng CC, Hung YJ, Lin SH, Tsai CS, Lin CS. Artificial Intelligence-Powered Rapid Identification of ST-Elevation Myocardial Infarction via Electrocardiogram (ARISE) - A Pragmatic Randomized Controlled Trial. NEJM AI. 2024 Jul;1(7):AIoa2400190. doi: 10.1056/AIoa2400190. Epub 2024 Jun 27.
PubMed 42932488
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
- ClinicalTrials.gov ID
- NCT05118009
- Acronym / sponsor ID
- NDMC2021003
- Conditions
- Myocardial Infarction, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43,176 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AI-enabled ECG-based Screening ToolPatients randomized to intervention will have access to the screening tool. |
| Control | No intervention | –Patients randomized to control will continue routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients in emergency department or inpatient department.
- Patients recieved at least 1 ECG examination.
Key exclusion criteria (1 listed)
- The patients recieved ECG at the period of inactive AI-ECG system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-enabled ECG-based Screening ToolPrimary 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. | Other | Intervention |
Primary outcome
E2C (ECG to coronary angiography) time
Time frame: Within 6 hours
Time from ECG to activation of coronary angiography for STEMI patients.
8 secondary outcomes
E2B (ECG to primary percutaneous coronary intervention) time
Time frame: Within 6 hours
D2B (Door to Balloon Time) time
Time frame: Within 6 hours
D2C (Door to coronary angiography) time
Time frame: Within 6 hours
Ejection fractrion
Time frame: Within 3 days
Highest concentration of high-sensitivity cardiac troponin I
Time frame: Within 3 days
Highest concentration of creatine kinase
Time frame: Within 3 days
Length of hospitalization
Time frame: Within 28 days
Number of CAG event
Time frame: Within 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 42932488Lin C, Liu WT, Chang CH, Lee CC, Hsing SC, Fang WH, Tsai DJ, Chen KC, Lee CH, Cheng CC, Hung YJ, Lin SH, Tsai CS, Lin CS. Artificial Intelligence-Powered Rapid Identification of ST-Elevation Myocardial Infarction via Electrocardiogram (ARISE) - A Pragmatic Randomized Controlled Trial. NEJM AI. 2024 Jul;1(7):AIoa2400190. doi: 10.1056/AIoa2400190. Epub 2024 Jun 27.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction, Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-enabled ECG-based Screening Tool in people with Myocardial Infarction, Acute, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
E2C (ECG to coronary angiography) time (time frame: Within 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.