Development and Clinical Application of a Foundational Model for Cardiovascular Disease Diagnosis and Prediction Based on Multimodal Medical Big Data
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000,000
- 试验地点
- 1
- 主要终点
- Area under ROC
研究概览
简要总结
The goal of this observational study is to develop and evaluate the efficacy of a foundational model that integrates multimodal medical data to improve the diagnosis and prediction of cardiovascular diseases in patients aged 18 and older, including those with various heart conditions such as coronary artery disease, heart failure, and arrhythmias. The main questions it aims to answer are:
Can a multimodal data-based diagnostic model match or exceed the accuracy of traditional gold-standard methods like coronary angiography, MRI, and echocardiography? Does integrating different types of data (ECG, imaging, biochemical tests) improve diagnostic accuracy and prediction of cardiovascular disease outcomes? Researchers will compare the foundational model with traditional diagnostic methods to see if the model offers better sensitivity, specificity, and prediction accuracy across different heart disease types.
Participants will:
Provide data from past medical records, including ECG, echocardiography, cardiac MRI, and biochemical tests.
Undergo further data collection if necessary, in line with standard clinical procedures for cardiovascular disease management.
详细描述
This study aims to develop and validate a foundational model that uses multimodal medical data for the diagnosis and prediction of cardiovascular diseases. By integrating data from ECG, echocardiography, cardiac MRI, CTA, nuclear imaging (SPECT/PET), and biochemical tests, the model seeks to improve diagnostic accuracy and predict disease outcomes.
Study Design Study Type: Retrospective, multicenter, observational study Study Population: Adults aged 18 and older, including patients with coronary artery disease (CAD), heart failure, arrhythmias, and valvular heart disease (VHD).
Objectives Primary Objective: To create a model that improves the diagnosis and prediction of cardiovascular diseases using multimodal data.
Secondary Objective: To compare the performance of the model against traditional diagnostic methods like coronary angiography, echocardiography, and MRI.
Methodology Data from 2009 to 2023 will be collected from multiple hospitals. The model will use deep learning techniques to integrate the data for more accurate diagnosis and prediction.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Age ≥ 18 years: Patients who are 18 years of age or older. Time period: Patients who were treated or diagnosed between January 1, 2009, and December 31,
- •Complete medical records: Patients with comprehensive medical records, including ECG, echocardiography, MRI, CTA, nuclear imaging (SPECT/PET), and biochemical test results.
- •Cardiovascular diseases: Patients with diagnosed cardiovascular conditions, such as coronary artery disease (CAD), heart failure, arrhythmias, and valvular heart disease (VHD), as well as healthy individuals for comparison.
- •Willingness to participate: Patients who are able to provide informed consent or their legal representatives.
排除标准
- •Participation in other clinical trials: Patients who are currently participating in other clinical trials that may affect the study outcomes.
- •Incomplete medical records: Patients whose medical records lack essential data, such as ECG, echocardiography, MRI, CTA, nuclear imaging (SPECT/PET), or biochemical test results.
- •Data quality issues: Patients with records that have significant errors, inconsistencies, or incomplete data that cannot be reasonably corrected.
- •Ethical or legal concerns: Patients whose data cannot be used due to a lack of necessary consent or legal/ethical restrictions.
结局指标
主要结局
Area under ROC
时间窗: 1 month
In this study, the area under the receiver operating characteristic curve (AUROC) will be used as a key performance metric to evaluate the diagnostic accuracy of the foundational model for cardiovascular diseases. The AUROC measures the model's ability to distinguish between patients with and without a specific condition, such as coronary artery disease, heart failure, or arrhythmias.
次要结局
未报告次要终点