NCT07163767

Brief Summary

The goal of this observational study is to develop and validate an artificial intelligence(AI)-based prediction model for new-onset acute myocardial infarction(AMI) using electrocardiogram(ECG) data. The main question it aims to answer is whether the AI-based ECG accurately forecast new-onset AMI by previous ECG data with 'normal' diagnosis?

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Aug 2025Dec 2028

Study Start

First participant enrolled

August 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 18, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

September 2, 2025

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acute myocardial infarction (AMI)

    AMI was defined as STEMI, NSTEMI using ICD-10.

    From June 2025 to April 2026

Study Arms (1)

Cardiorenal ImprovemeNt II (CIN-II)

This is a multi-center, retrospective observation study collecting data on 184855 coronary angiography patients from January 2000 to Decemeber 2020.

Other: Deep learning approach of ECG for AMI detection

Interventions

AMIdECG was trained to perform AMI detection in a supervised manner as a classification task. And the classification labels of AMI subtypes (" STEMI "or" NSTEMI ") or non-AMI states used during the training phase are real-world diagnostic results

Cardiorenal ImprovemeNt II (CIN-II)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In-hospital patients with ECG records

You may qualify if:

  • Hospitalized in cardiology department with myocardial injury marker testing (troponin T/I).
  • In-hospital patients with ECG records.

You may not qualify if:

  • First ECG obtained in emergency department.
  • ACS diagnosis within 1 month of first ECG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (33)

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Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 9, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

December 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations