Coronary Heart Disease (CHD)CorAINCT07766551
Construction and Validation of a Coronary Artery Disease-Specific Large Language Model and Its Evaluation Framework (CorAI)
An observational study of Coronary Heart Disease (CHD) and Artifical Intelligence, run by China National Center for Cardiovascular Diseases at 3 sites in China.
Trial summary
Coronary artery disease (CAD) affects an estimated 11.39 million people in China, and mortality has continued to rise since 2012. Quality-of-care data indicate persistent gaps in diagnostic and therapeutic guideline adherence, incomplete implementation of secondary prevention, and suboptimal risk-factor control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease (CHD), Artifical Intelligence
- How many people
- 640 participants
- Where
- 3 sitesChina
- Study dates
- 17 Aug 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed or suspected coronary heart disease.
Who may be able to join
- Age ≥ 18 years;
- Patients with confirmed or suspected coronary heart disease;
- Complete case information (including medical history, test results, imaging, follow-up records, etc.);
- Consent for the use of case data for model evaluation and research analysis.
Who cannot join
- Cases with severe data gaps that prevent the formation of a complete clinical scenario;
- Cases where the primary diagnosis is not coronary heart disease;
- Cases with serious data errors or where data cannot be anonymized.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Prof. Gao, MD, PhD, +861088322413, sophie_gao@sina.com
Prof. Gao, MD, PhD, sophie_gao@sina.com
The First Affiliated Hospital of USTC
Hefei, Anhui, 230001
Hongwu Chen, MD, +86-551-62283114, 1025707914@qq.com
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518057
Fenghuan Hu, MD, 0755-25509566, hufenghuanvip@163.com
About this study
Official title: A Prospective, Multicenter, Observational Cohort Study for the Construction of a Multimodal Coronary Artery Disease Dataset and the Development, Evaluation, and External Validation of a Disease-Specific Large Language Model (CorAI)
Coronary artery disease (CAD) affects an estimated 11.39 million people in China, and mortality has continued to rise since 2012. Quality-of-care data indicate persistent gaps in diagnostic and therapeutic guideline adherence, incomplete implementation of secondary prevention, and suboptimal risk-factor control. Large language models (LLMs) can rapidly retrieve and integrate literature, medical records, and multimodal clinical data, and may support clinical decision-making. However, most existing medical LLMs are general-purpose, are trained predominantly on published literature and web text rather than authentic clinical records, and have not been validated with real patient data. No disease-specific LLM for CAD currently exists, and no evaluation framework tailored to CAD has been established; existing benchmarks are general-purpose, lack specialty-specific risk grading, are not rigorously anchored to current guidelines, and emphasize literal accuracy over clinically critical reasoning steps and prescription concordance.
This prospective, multicenter, observational study will enroll approximately 640 patients with confirmed or suspected CAD at Fuwai Hospital and collaborating centers. No study-specific intervention, examination, biospecimen collection, or additional follow-up visit is performed; all clinical decisions are made independently by the treating physician according to routine standards of care. For consenting participants, routinely generated clinical documentation from the index outpatient visit or hospitalization - including medical history, laboratory results, imaging and coronary angiography/coronary CT angiography reports, physician notes, online consultation records, and follow-up records - will be de-identified and used to construct a high-quality multimodal CAD dataset. This dataset will support the development of a CAD-specific large language model (CorAI), the construction of an evaluation framework spanning eight predefined clinical scenarios and multiple assessment dimensions, and external validation of the model at participating centers.
The primary objectives are to characterize the completeness and quality of the constructed prospective cohort dataset, and to quantify the guideline concordance of CorAI-generated clinical recommendations as adjudicated by a blinded panel of cardiologists.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Artificial Intelligence, Large Language Models, Coronary Heart Disease (CHD)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| CorAI development and evaluation cohort | Adults aged 18 years or older with confirmed or suspected coronary artery disease presenting for routine outpatient or inpatient care at a participating center. Routinely generated clinical documentation is de-identified and used for construction of a multimodal CAD dataset and for development and evaluation of a disease-specific large language model. No study-specific intervention, testing, or follow-up is performed. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of the constructed multimodal CAD dataset
Proportion of enrolled participants whose de-identified record satisfies all pre-specified data-completeness criteria, defined as the presence of medical history, comorbidity and medication documentation, laboratory results, electrocardiography, coronary CT angiography and/or invasive coronary angiography findings, and at least one structured follow-up or discharge record sufficient to reconstruct a complete clinical scenario. Reported as a percentage with 95% confidence interval.
Measured: From enrollment of the first participant through completion of dataset construction, up to 12 months
Secondary outcomes (1)
Guideline concordance of CorAI-generated clinical recommendations across eight predefined coronary artery disease scenarios
Proportion of CorAI responses judged fully concordant with the coronary artery disease clinical practice guidelines in force at the time of adjudication, assessed on the held-out evaluation set across eight predefined clinical scenarios: (1) initial evaluation of chest pain; (2) coronary artery assessment; (3) antithrombotic therapy; (4) revascularization decision-making; (5) lipid-lowering therapy; (6) post-procedural management; (7) post-procedural complications; and (8) patient education and physician-patient communication. Each item is scored as concordant, partially concordant, or discordant by cardiologists blinded to response source using a pre-specified rubric, with disagreements resolved by an independent third adjudicator. The primary metric is the pooled percentage of items scored fully concordant across all eight scenarios, reported with a 95% confidence interval.
Measured: At completion of model development and evaluation, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Aug 2027 (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 China National Center for Cardiovascular DiseasesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766551
- Sponsor's protocol ID
- 2025-GSP-GG-18-3
- Other IDs
- 2025-GSP-GG-18
- Acronym
- CorAI
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data underlying reported results may be made available on reasonable request to the corresponding author, subject to approval by the Ethics Committee of Fuwai Hospital and to compliance with applicable Chinese regulations governing the cross-border transfer of human genetic resources and health data. The study protocol and the pre-specified evaluation rubric will be made available alongside publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Cohort Study for the Construction of a Multimodal Coronary Artery Disease Dataset and the Development, Evaluation, and External Validation of a Disease-Specific Large Language Model (CorAI)
- ClinicalTrials.gov ID
- NCT07766551
- Acronym / sponsor ID
- CorAI / 2025-GSP-GG-18-3
- Keywords
- Artificial Intelligence, Large Language Models, Coronary Heart Disease (CHD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Aug 2026 (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.
Coronary artery disease (CAD) affects an estimated 11.39 million people in China, and mortality has continued to rise since 2012. Quality-of-care data indicate persistent gaps in diagnostic and therapeutic guideline adherence, incomplete implementation of secondary prevention, and suboptimal risk-factor control. Large language models (LLMs) can rapidly retrieve and integrate literature, medical records, and multimodal clinical data, and may support clinical decision-making. However, most existing medical LLMs are general-purpose, are trained predominantly on published literature and web text rather than authentic clinical records, and have not been validated with real patient data. No disease-specific LLM for CAD currently exists, and no evaluation framework tailored to CAD has been established; existing benchmarks are general-purpose, lack specialty-specific risk grading, are not rigorously anchored to current guidelines, and emphasize literal accuracy over clinically critical reasoning steps and prescription concordance.
This prospective, multicenter, observational study will enroll approximately 640 patients with confirmed or suspected CAD at Fuwai Hospital and collaborating centers. No study-specific intervention, examination, biospecimen collection, or additional follow-up visit is performed; all clinical decisions are made independently by the treating physician according to routine standards of care. For consenting participants, routinely generated clinical documentation from the index outpatient visit or hospitalization - including medical history, laboratory results, imaging and coronary angiography/coronary CT angiography reports, physician notes, online consultation records, and follow-up records - will be de-identified and used to construct a high-quality multimodal CAD dataset. This dataset will support the development of a CAD-specific large language model (CorAI), the construction of an evaluation framework spanning eight predefined clinical scenarios and multiple assessment dimensions, and external validation of the model at participating centers.
The primary objectives are to characterize the completeness and quality of the constructed prospective cohort dataset, and to quantify the guideline concordance of CorAI-generated clinical recommendations as adjudicated by a blinded panel of cardiologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CorAI development and evaluation cohort | – | Other: No Intervention: Observational CohortAdults aged 18 years or older with confirmed or suspected coronary artery disease presenting for routine outpatient or inpatient care at a participating center. Routinely generated clinical documentation is de-identified and used for construction of a multimodal CAD dataset and for development and evaluation of a disease-specific large language model. No study-specific intervention, testing, or follow-up is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed or suspected coronary heart disease.
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Patients with confirmed or suspected coronary heart disease;
- Complete case information (including medical history, test results, imaging, follow-up records, etc.);
- Consent for the use of case data for model evaluation and research analysis.
Key exclusion criteria (3 listed)
- Cases with severe data gaps that prevent the formation of a complete clinical scenario;
- Cases where the primary diagnosis is not coronary heart disease;
- Cases with serious data errors or where data cannot be anonymized.
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 Intervention: Observational CohortNo Intervention: Observational Cohort | Other | CorAI development and evaluation cohort |
Primary outcome
Completeness of the constructed multimodal CAD dataset
Time frame: From enrollment of the first participant through completion of dataset construction, up to 12 months
Proportion of enrolled participants whose de-identified record satisfies all pre-specified data-completeness criteria, defined as the presence of medical history, comorbidity and medication documentation, laboratory results, electrocardiography, coronary CT angiography and/or invasive coronary angiography findings, and at least one structured follow-up or discharge record sufficient to reconstruct a complete clinical scenario. Reported as a percentage with 95% confidence interval.
1 secondary outcome
Guideline concordance of CorAI-generated clinical recommendations across eight predefined coronary artery disease scenarios
Time frame: At completion of model development and evaluation, up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data underlying reported results may be made available on reasonable request to the corresponding author, subject to approval by the Ethics Committee of Fuwai Hospital and to compliance with applicable Chinese regulations governing the cross-border transfer of human genetic resources and health data. The study protocol and the pre-specified evaluation rubric will be made available alongside publication.
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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.
3 sites 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 Artifical Intelligence, run by China National Center for Cardiovascular Diseases at 3 sites 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 3 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Gao (+861088322413, sophie_gao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness of the constructed multimodal CAD dataset (time frame: From enrollment of the first participant through completion of dataset construction, up to 12 months). 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 14 Aug 2026.