Coronary Heart Disease (CHD)NCT06591923
a Foundational Model for Cardiovascular Disease Diagnosis and Prediction
An observational study of Coronary Heart Disease (CHD) and Heart Failure, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease (CHD), Heart Failure, Arrhythmias
- How many people
- 1,000,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2024to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Yixiu Liang, MD, +8602164041990, liang.yixiu@zs-hospital.sh.cn
About this study
Official title: Development and Clinical Application of a Foundational Model for Cardiovascular Disease Diagnosis and Prediction Based on Multimodal Medical Big Data
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.
Read more
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.
Read the detailed description
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.
The performance of the model will be compared with current gold-standard methods.
Expected Outcomes Improved diagnostic accuracy and early disease detection. Enhanced prediction of long-term outcomes, allowing for better treatment planning.
- Being tested
- No Interventions
- Keywords
- foundation model, artificial intelligence
- Medical subject headings
- Coronary Disease, Heart Failure, Arrhythmias, Cardiac, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591923
- Sponsor's protocol ID
- CardioVerse
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Application of a Foundational Model for Cardiovascular Disease Diagnosis and Prediction Based on Multimodal Medical Big Data
- ClinicalTrials.gov ID
- NCT06591923
- Acronym / sponsor ID
- CardioVerse
- Keywords
- foundation model, artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The performance of the model will be compared with current gold-standard methods.
Expected Outcomes Improved diagnostic accuracy and early disease detection. Enhanced prediction of long-term outcomes, allowing for better treatment planning.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo interventions. | Other | – |
Primary outcome
Area under ROC
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Coronary Heart Disease (CHD)
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease (CHD) and Heart Failure, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yixiu Liang, MD (800-555-5850, liang.yixiu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under ROC (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.