a Foundational Model for Cardiovascular Disease Diagnosis and Prediction

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population will consist of adult patients aged 18 years and older who have been diagnosed with or are at risk of developing cardiovascular diseases. This population includes individuals with a variety of heart conditions such as: Coronary artery disease (CAD) Heart failure Arrhythmias Valvular heart disease (VHD) Additionally, healthy individuals with no history of cardiovascular disease will also be included for comparative analysis. The study population will be drawn from multiple hospitals and centers, and the data will cover the period from January 1, 2009, to December 31, 2023.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • No Interventions

    Other intervention

    No interventions.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Area under ROC

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.

Time frame
1 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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