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This research aims to evaluate a comprehensive AI-driven workflow for both clinical data extraction and diagnostic classification in coronary artery disease (CAD). Leveraging OCR and Large Language Models (LLMs), the system is designed to extract ten key clinical parameters (such as LVEF and lab results) and provide diagnostic subtypes (UA, STEMI, NSTEMI, CCS) directly from unstructured inpatient records. A man-machine comparative trial will be conducted using a test set of 308 patients, where the performance of the LLM-based workflow will be benchmarked against the average diagnostic accuracy and processing time of seven clinical physicians. The findings will provide evidence for the feasibility of using LLMs to enhance clinical data structuring and diagnostic efficiency in cardiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Cohort | This group consists of 50 patient records from the AIM-CHD Study at Fuwai Hospital. These data are specifically utilized for refining OCR processing and optimizing Prompt Engineering for the LLM-based workflow. |
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| Internal Validation Cohort | This cohort includes 188 clinical cases sourced from the SMART-CHD Study at Fuwai Hospital. These records serve as the primary internal benchmark to evaluate the diagnostic and extraction accuracy of the LLM workflow against the established ground truth. |
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| External Validation Cohort | This cohort comprises 70 patient records collected from 8 independent sub-centers (excluding Fuwai Hospital) to assess the generalizability and robustness of the model across diverse clinical environments and different medical record formats. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCR-Prompt-LLM Information Extraction Workflow | Device | The intervention is an automated clinical data management system integrating Optical Character Recognition (OCR), optimized Prompt Engineering, and Large Language Models (LLMs). The workflow processes unstructured inpatient records to extract 10 key clinical indicators (e.g., LVEF, CAD subtypes, medications) and classifies the patient into specific coronary artery disease categories (UA, STEMI, NSTEMI, CCS) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Diagnostic and Extraction Accuracy Rate | To calculate the overall accuracy rate of the LLM-based workflow across 308 cases (including the pilot set, internal validation cohort, and external validation cohort) for 10 clinical indicators (e.g., LVEF, blood glucose, etc.) and 4 diagnostic subtypes of coronary artery disease. Accuracy is defined as the proportion of cases where the LLM's extraction or diagnostic results are perfectly consistent with the 'Gold Standard' established by human clinical experts. | Through study completion, an average of 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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he study population consists of 308 patients diagnosed with various subtypes of coronary artery disease (CAD). The cohort is derived from two major clinical studies: the AIM-CHD study (for pilot testing and prompt optimization) and the SMART-CHD study (for internal validation), both conducted at Fuwai Hospital. Additionally, an external validation cohort is included, comprising patients from 8 independent clinical sub-centers across China to ensure geographical and institutional diversity. The population covers a spectrum of CAD presentations, including Unstable Angina (UA), STEMI, NSTEMI, and Chronic Coronary Syndrome (CCS), providing a robust dataset for evaluating AI-driven diagnostic and data extraction performance.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | 100037 | China |
To protect patient privacy and comply with the data management policies of the participating institutions (Fuwai Hospital and sub-centers), individual participant data will not be made publicly available. However, aggregated study results and statistical analyses will be included in the final publication.
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| Manual Clinical Data Review | Device | Standard manual process where experienced clinical physicians collect and interpret patient information from medical records. This serves as the human benchmark for comparing diagnostic accuracy and operational efficiency. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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