OMI - Occlusion Myocardial InfarctionNCT06887699
The Impact of Artificial Intelligence Electrocardiography on Occlusion Myocardial Infarction Management Under the Value-Based Payment System
A study testing AI-ECG P4P program in people with OMI - Occlusion Myocardial Infarction and Artificial Intelligence (AI), run by National Defense Medical Center, Taiwan at 3 sites in Taiwan.
Trial summary
This trial will prospectively evaluate the impact of integrating AI-ECG within the pay-for-performance program on improving the diagnosis, treatment, and clinical outcomes of occlusion myocardial infarction patients by promoting accurate and timely diagnoses through financial incentives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OMI - Occlusion Myocardial Infarction, Artificial Intelligence (AI), Electrocardiogram
- What is being tested?
- AI-ECG P4P program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212,000 participants
- Where
- 3 sitesTaiwan
- Study dates
- 1 Aug 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 the emergency department
- Patients received at least 1 ECG examination.
Who cannot join
- The patients received ECG at the period of inactive AI-ECG system.
- Patients with a history of coronary angiography within the past 3 days.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
Kaohsiung Armed Forces General Hospital
Kaohsiung City, Taiwan, 807
CHIN LIN, 0958259269, xup6fup0629@gmail.com
- Recruiting
Taipei Municipal Wanfang Hospital
Taipei, 114
CHIN LIN, 0958259269, xup6fup0629@gmail.com
- Recruiting
Tri-Service General Hospital
Taipei, 114
Yuan-Hao Chen, PhD, +886287923311, chenyh178@gmail.com
About this study
Official title: A Randomized Clinical Trial Investigating the Impact of Artificial Intelligence Electrocardiography on Occlusion Myocardial Infarction Management Under the Value-Based Payment System
This trial will prospectively evaluate the impact of integrating AI-ECG within the pay-for-performance program on improving the diagnosis, treatment, and clinical outcomes of occlusion myocardial infarction patients by promoting accurate and timely diagnoses through financial incentives.
Read the detailed description
The investigators have developed an AI-ECG system that provides real-time notifications for patients with potential occlusion myocardial infarction. This AI algorithm is seamlessly integrated into the Hospital Information System, allowing for the automatic generation of reports whenever an ECG is performed. The purpose of this study is to evaluate the impact of AI-ECG on the timely diagnosis of STEMI, including patients' outcomes and healthcare costs.
- Conditions
- OMI - Occlusion Myocardial Infarction, Artificial Intelligence (AI), Electrocardiogram, Cost-effectiveness Analysis
- Being tested
- AI-ECG P4P program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-ECG P4P programOther
The AI-ECG system will conduct a real-time analysis of the ECG. When the system identifies potential OMI cases, it will immediately send short message service notifications to the on-duty cardiologists. This will enable the cardiologists to promptly review and confirm the diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| AI-ECG P4P program | Experimental | AI-ECG-assisted detection of OMI within the P4P program. The AI-ECG system will conduct a real-time analysis of the ECG. When the system identifies potential OMI cases, it will immediately send short message service notifications to the on-duty cardiologists. This will enable the cardiologists to promptly review and confirm the diagnosis. Receives: Other: AI-ECG P4P program |
| Standard of care | No intervention | Potential OMI patients will be initially assessed by frontline physicians. If OMI is suspected, the frontline physicians will promptly notify the on-duty cardiologists, who will then review the case for confirmation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-to-W time (Door to Wire Time)
Door-to-wire time refers to the duration from a patient's arrival at the emergency department (ED) to the successful placement of a wire into the coronary artery during a primary percutaneous coronary intervention (PPCI) procedure.
Measured: From the start of the emergency visit to the following 48 hours.
Cost Outcome Measure
Total expenditures, from the start of the emergency visit to 90 days post-discharge (in USD), for comparison between the intervention and control groups, based on records from NHI (National Health Insurance) claims data.
Measured: From the start of the emergency visit to 90 days post-discharge.
Secondary outcomes (15)
Door-to-Wire time less than 90 minutes
The proportion of patients achieving a Door-to-Wire time of less than 90 minutes in the intervention group compared to the control group. The intervention and control groups' door-to-wire time will be compared. Door-to-wire time is defined as the duration from the first ECG to the successful placement of the wire during PPCI for OMI patients in the emergent department.
Measured: 48 hours
In-hospital all-cause Mortality Rate
The proportion of patients who die from any cause, regardless of the underlying condition, during hospitalization.
Measured: 90-day follow
In-hospital cardiac death
The proportion of patients who die from cardiovascular-related causes during hospitalization.
Measured: 90-day follow
Length of ICU
Comparison of length of ICU between the intervention and control groups.
Measured: 90-day follow
Length of hospitalization
Comparison of length of hospitalization between the intervention and control groups.
Measured: 90-day follow
Cardiovascular events
Composite cardiovascular events (Non-fatal MI + Non-fatal stroke + CV Death) The rate of composite cardiovascular events within 90 days.
Measured: 90-day follow
Non-fatal MI
The rate of non-fatal MI within 90-days.
Measured: 90-day follow
Non-fatal stroke (Ischemic stroke + Hemorrhagic stroke)
The rate of non-fatal strokes (both ischemic and hemorrhagic) within 90-days.
Measured: 90-day follow
Cardiac Death
The proportion of patients who die from cardiovascular-related causes within 90-days.
Measured: 90-day follow
Ischemic stroke
The incidence of ischemic stroke.
Measured: 90-day follow
Hemorrhagic stroke
The incidence of hemorrhagic stroke.
Measured: 90-day follow
All-cause mortality
The proportion of patients who die from any cause within 90-days.
Measured: 90-day follow
Coronary artery bypass grafting (CABG)
The rate of patients who undergo coronary artery bypass surgery (CABG) within 90-days following OMI treatment.
Measured: 90-day follow
Heart failure admission
The rate of hospital admissions for heart failure within 90-days following OMI treatment.
Measured: 90-day follow
Re-hospitalization (from any cause)
The rate of readmission to the hospital within 90-days of discharge.
Measured: 90-day follow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Aug 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OMI - Occlusion Myocardial InfarctionStudies 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
- 212,000 participants (estimated)
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
- Investigators
- Chin Lin, PhD, Principal investigator, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887699
- Sponsor's protocol ID
- A202505035
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Investigating the Impact of Artificial Intelligence Electrocardiography on Occlusion Myocardial Infarction Management Under the Value-Based Payment System
- ClinicalTrials.gov ID
- NCT06887699
- Acronym / sponsor ID
- A202505035
- Conditions
- OMI - Occlusion Myocardial Infarction, Artificial Intelligence (AI), Electrocardiogram, Cost-effectiveness Analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212,000 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Mar 2025 (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 trial will prospectively evaluate the impact of integrating AI-ECG within the pay-for-performance program on improving the diagnosis, treatment, and clinical outcomes of occlusion myocardial infarction patients by promoting accurate and timely diagnoses through financial incentives.
Detailed description
The investigators have developed an AI-ECG system that provides real-time notifications for patients with potential occlusion myocardial infarction. This AI algorithm is seamlessly integrated into the Hospital Information System, allowing for the automatic generation of reports whenever an ECG is performed. The purpose of this study is to evaluate the impact of AI-ECG on the timely diagnosis of STEMI, including patients' outcomes and healthcare costs.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-ECG P4P program | Experimental | Other: AI-ECG P4P programAI-ECG-assisted detection of OMI within the P4P program. The AI-ECG system will conduct a real-time analysis of the ECG. When the system identifies potential OMI cases, it will immediately send short message service notifications to the on-duty cardiologists. This will enable the cardiologists to promptly review and confirm the diagnosis. |
| Standard of care | No intervention | –Potential OMI patients will be initially assessed by frontline physicians. If OMI is suspected, the frontline physicians will promptly notify the on-duty cardiologists, who will then review the case for confirmation. |
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 the emergency department
- Patients received at least 1 ECG examination.
Key exclusion criteria (2 listed)
- The patients received ECG at the period of inactive AI-ECG system.
- Patients with a history of coronary angiography within the past 3 days.
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-ECG P4P programThe AI-ECG system will conduct a real-time analysis of the ECG. When the system identifies potential OMI cases, it will immediately send short message service notifications to the on-duty cardiologists. This will enable the cardiologists to promptly review and confirm the diagnosis. | Other | AI-ECG P4P program |
Primary outcome
D-to-W time (Door to Wire Time)
Time frame: From the start of the emergency visit to the following 48 hours.
Door-to-wire time refers to the duration from a patient's arrival at the emergency department (ED) to the successful placement of a wire into the coronary artery during a primary percutaneous coronary intervention (PPCI) procedure.
Cost Outcome Measure
Time frame: From the start of the emergency visit to 90 days post-discharge.
Total expenditures, from the start of the emergency visit to 90 days post-discharge (in USD), for comparison between the intervention and control groups, based on records from NHI (National Health Insurance) claims data.
15 secondary outcomes
Door-to-Wire time less than 90 minutes
Time frame: 48 hours
In-hospital all-cause Mortality Rate
Time frame: 90-day follow
In-hospital cardiac death
Time frame: 90-day follow
Length of ICU
Time frame: 90-day follow
Length of hospitalization
Time frame: 90-day follow
Cardiovascular events
Time frame: 90-day follow
Non-fatal MI
Time frame: 90-day follow
Non-fatal stroke (Ischemic stroke + Hemorrhagic stroke)
Time frame: 90-day follow
Cardiac Death
Time frame: 90-day follow
Ischemic stroke
Time frame: 90-day follow
Hemorrhagic stroke
Time frame: 90-day follow
All-cause mortality
Time frame: 90-day follow
Coronary artery bypass grafting (CABG)
Time frame: 90-day follow
Heart failure admission
Time frame: 90-day follow
Re-hospitalization (from any cause)
Time frame: 90-day follow
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Chin Lin, PhD principal investigator
National Defense Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-ECG P4P program in people with OMI - Occlusion Myocardial Infarction and Artificial Intelligence (AI), run by National Defense Medical Center, Taiwan at 3 sites 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 2 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin Lin, PhD (+886-2-8792-3100 ext. 18574, xup6fup@mail.ndmctsgh.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
D-to-W time (Door to Wire Time) (time frame: From the start of the emergency visit to the following 48 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.