NCT06887699

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212,000

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Aug 2025Jun 2028

First Submitted

Initial submission to the registry

March 4, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

March 4, 2025

Last Update Submit

April 6, 2026

Conditions

OMI - Occlusion Myocardial InfarctionArtificial Intelligence (AI)ElectrocardiogramCost-effectiveness Analysis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From the start of the emergency visit to 90 days post-discharge.

Secondary Outcomes (15)

  • Door-to-Wire time less than 90 minutes

    48 hours

  • In-hospital all-cause Mortality Rate

    90-day follow

  • In-hospital cardiac death

    90-day follow

  • Length of ICU

    90-day follow

  • Length of hospitalization

    90-day follow

  • +10 more secondary outcomes

Other Outcomes (6)

  • Emergent CAG without PCI

    From the start of the emergency visit to the following 48 hours.

  • Procedure related vascular complications

    From the start of the emergency visit to the following 48 hours.

  • Contrast-induced acute kidney injury

    90-day follow

  • +3 more other outcomes

Study Arms (2)

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.

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.

Interventions

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.

AI-ECG P4P program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in the emergency department
  • Patients received at least 1 ECG examination.

You may not qualify if:

  • The patients received ECG at the period of inactive AI-ECG system.
  • Patients with a history of coronary angiography within the past 3 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaohsiung Armed Forces General Hospital

Kaohsiung City, Taiwan, 807, Taiwan

RECRUITING

Taipei Municipal Wanfang Hospital

Taipei, 114, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

Study Officials

  • Chin Lin, PhD

    National Defense Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin Lin, PhD

CONTACT

+886-2-8792-3100xup6fup@mail.ndmctsgh.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 20, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)