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临床试验/NCT07163767
NCT07163767进行中(未招募)不适用

Acute Myocardial Infarction Prediction Using Artificial Intelligence Applied to Electrocardiogram Images

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 150,000 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150,000
试验地点
1
主要终点
Acute myocardial infarction (AMI)

研究概览

简要总结

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?

详细描述

Myocardial infarction (MI), as one of the most critical acute clinical events in cardiovascular diseases, has high morbidity and mortality, imposing a significant burden on public health and medical resources. Traditional risk assessment for MI relies on clinical indicators (e.g., lipids, blood pressure, diabetes status, family history) and cardiac imaging, but these methods often suffer from invasive procedure, high cost, or limited predictive accuracy. Electrocardiography (ECG), a non-invasive, widely available, and low-cost modality, captures rich electrophysiological signals reflecting cardiac function. However, conventional analysis methods struggle to detect subtle, progressive patterns in ECG signals, leading to sub-optimal sensitivity and specificity in predicting new-onset MI.

Recent advancements in deep learning and big data have enabled significant progress in ECG-based prediction models. For example, deep convolutional neural networks (CNNs) for automatic feature extraction and pattern recognition from 12-lead ECGs have demonstrated promise in predicting cardiovascular events such as atrial fibrillation, left ventricular hypertrophy, and heart failure re-hospitalization. AI algorithms have also been shown to extract subtle information from ECGs that traditional methods miss, such as dynamic changes in ventricular electrical activity and early signs of micro-myocardial injury, enabling early risk warning of cardiac events. While numerous ECG-based AI models exist for predicting arrhythmia , heart failure, and other cardiovascular outcomes, research on predicting new-onset MI-particularly using non-invasive ECG data and deep learning to extract latent predictive markers-remains in its infancy. Traditional risk models, though successful in MI prevention, lack precision in individual-level prediction and early intervention.

This study aims to leverage large-scale electronic health records and ECG datasets with advanced deep learning to explore the quantitative relationship between fine-grained ECG signal features and MI incidence, thereby developing a clinical tool for early risk assessment. Inspirations also derive from recent attempts to build multi-modal prediction models combining ECG with physiological, genetic, and biochemical markers. Additionally, studies have highlighted ECG's unique advantages in evaluating myocardial compensatory mechanisms and early injury. Despite existing ECG-AI applications, direct prediction of new-onset MI remains a critical unmet need and a key direction for precision medicine using AI.

This is a multi-center observational cohort study. Large-scale in-hospital ECG data will be integrated to develop a deep learning model for MI prediction using an end-to-end deep neural network approach, with the goal of deriving a high-performance model for new-onset MI prediction. The ECG data from 5 multicenter Cardiorenal ImprovemeNt II (CIN-II) sites between 2010-2023 will be assessed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Acute myocardial infarction (AMI)

时间窗: From June 2025 to April 2026

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu yong

Professor

Guangdong Provincial People's Hospital

研究点 (1)

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