a Foundational Model for Cardiovascular Disease Diagnosis and Prediction

NCT06591923 | Not Yet Recruiting

• 1 other identifier: CardioVerse
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease (CHD); Heart Failure; Arrhythmias; Valvular Heart Disease

Keywords

foundation model; artificial intelligence

Outcome Measures

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.

  1 month

Interventions

No Interventions OTHER

No interventions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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, 2023.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Coronary Disease; Heart Failure; Arrhythmias, Cardiac; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yixiu Liang, MD

CONTACT

800-555-5850; liang.yixiu@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)