Construction and Validation of a Coronary Artery Disease-Specific Large Language Model and Its Evaluation Framework (CorAI)
CorAI
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)
2 other identifiers
observational
640
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2026
CompletedFirst Posted
Study publicly available on registry
August 14, 2026
CompletedStudy Start
First participant enrolled
August 17, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
Study Completion
Last participant's last visit for all outcomes
August 31, 2027
August 14, 2026
August 1, 2026
5 months
August 11, 2026
August 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
At completion of model development and evaluation, up to 18 months
Study Arms (1)
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.
Interventions
No Intervention: Observational Cohort
Eligibility Criteria
Patients with confirmed or suspected coronary heart disease.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The First Affiliated Hospital of USTC
Hefei, Anhui, 230001, China
Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518057, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2026
First Posted
August 14, 2026
Study Start (Estimated)
August 17, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
August 14, 2026
Record last verified: 2026-08