Construction and Validation of a Coronary Artery Disease-Specific Large Language Model and Its Evaluation Framework (CorAI) (CorAI)

August 11, 2026 updated by: China National Center for Cardiovascular Diseases

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

640

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • The First Affiliated Hospital of USTC
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
        • Contact:
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518057
        • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed or suspected coronary heart disease.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No Intervention: Observational Cohort
No Intervention: Observational Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment of the first participant through completion of dataset construction, up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
At completion of model development and evaluation, up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-GSP-GG-18-3
  • 2025-GSP-GG-18 (Other Grant/Funding Number: the National High Level Hospital Clinical Research Funding (China))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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