An observational study in Coronary Heart Disease (CHD) and Artifical Intelligence, sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by China National Center for Cardiovascular Diseases · Observational
Among 25 studies in Coronary Disease by China National Center for Cardiovascular Diseases — 12 open to participants now, 13 under way, none of them phase 3. Coronary Disease · China National Center for Cardiovascular Diseases.
Among the 25 studies in Coronary Disease by China National Center for Cardiovascular Diseases, this one is the 11th largest by planned enrollment of the 12 observational ones that give a count, is one of 4 that started in 2026, is one of 12 observational ones, reaches primary completion later than 7 of the 12 other live ones, and was the 24th registered.
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
Browse Coronary Disease studies →12 of the 25 studies in Coronary Disease by China National Center for Cardiovascular Diseases are open now, in 1 country. Recruiting first, the newest first:
China National Center for Cardiovascular Diseases · Sites in China
China National Center for Cardiovascular Diseases · Sites in China
China National Center for Cardiovascular Diseases · Sites in China
China National Center for Cardiovascular Diseases · Sites in China
China National Center for Cardiovascular Diseases · Sites in China
By country, each count listing its studies:
Of the 106 Coronary Disease studies recruiting now, 64 (60%) set no upper age limit and 19 (18%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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25 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 640 is below the median of 916 across 478 observational studies indexed under Coronary Disease.
Median enrollment 240 across the 13 interventional studies, 5,000 across the 12 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.
4 of the studies in Coronary Disease by China National Center for Cardiovascular Diseases that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07259278China National Center for Cardiovascular DiseasesIntelligent Management Platform for Guiding Exercise Rehabilitation in Coronary Heart Disease Patients | 2026-11-30 |
| NCT07230847China National Center for Cardiovascular DiseasesA Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography | 2026-12-31 |
| NCT07766551China National Center for Cardiovascular DiseasesConstruction and Validation of a Coronary Artery Disease-Specific Large Language Model and Its Evaluation Framework (CorAI) | 2027-01-01 |
| NCT07004452China National Center for Cardiovascular DiseasesMulti-modal Adverse Events Prediction for Premature Coronary Heart Disease Trial: MAP-CHD Trial | 2027-07 |
Among the 25 studies in Coronary Disease by China National Center for Cardiovascular Diseases, from their registry updates:
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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.
Patients with confirmed or suspected coronary heart disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Time frame: From enrollment of the first participant through completion of dataset construction, up to 12 months
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.
Time frame: At completion of model development and evaluation, up to 18 months
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jan 2027, 4 months later.
Of 132 non-industry observational studies under Coronary Disease, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 4 months is below that.
Counting every sponsor, half of 154 studies reached it within 47 months; a quarter within 21 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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China National Center for Cardiovascular Diseases →