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| ID | Type | Description | Link |
|---|---|---|---|
| Sponsor | Other Grant/Funding Number | China National Center for Cardiovascular Diseases |
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This study develops and validates a privacy-preserving OCR-LLM pipeline that converts admission history of present illness (HPI) records into structured coronary syndrome subtypes (STEMI, NSTEMI, unstable angina, and chronic coronary syndrome). The system first extracts text from de-identified HPI images using locally deployed OCR, then applies large language models with a fixed diagnostic prompt to generate subtype classification and evidence. Performance is evaluated in an internal validation cohort and multiple external datasets covering heterogeneous EHR templates, emergency department cases, and an English dataset from MIMIC-IV. A clinician usability study assesses changes in diagnostic accuracy and time with and without tool assistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal Development and Validation Cohort | Retrospective cohort used for model development and internal validation. Inputs are de-identified admission HPI records (image or text) from the AIM-CHD dataset. Expert adjudication provides the reference standard labels for 4-class coronary syndrome subtyping (STEMI, NSTEMI, unstable angina, chronic coronary syndrome). |
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| Multicenter External Validation Cohort | Retrospective multicenter cohort used for external validation across heterogeneous EHR templates and documentation styles. De-identified admission HPI records are processed through the same OCR-LLM pipeline, and predictions are compared with expert adjudicated reference labels to assess generalizability. |
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| Emergency Department External Validation Cohort | Retrospective cohort representing real-world emergency department workflow. De-identified ED admission HPI records are used to evaluate model performance under time-sensitive, information-limited conditions and assess robustness to ED documentation variability. |
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| English EHR External Validation Cohort | Retrospective cohort derived from the public de-identified MIMIC-IV database. English admission notes/HPI text are used to evaluate cross-language transportability and performance of the same classification prompts and post-processing rules against reference labels derived by adjudication/structured diagnosis mapping (as prespecified in the protocol). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM) | Device | An automated clinical data management workflow integrating Optical Character Recognition (OCR), optimized prompt engineering, and large language models (LLMs). The system processes unstructured inpatient/ED records (primarily admission history of present illness and related narrative text) to extract prespecified key clinical indicators (e.g., left ventricular ejection fraction, coronary syndrome subtype, medications) and to classify cases into prespecified coronary artery disease categories (e.g., unstable angina, STEMI, NSTEMI, chronic coronary syndrome). The workflow outputs structured fields and a classification result with supporting evidence excerpts. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall classification accuracy | Time Frame: Up to completion of dataset evaluation (internal + external cohorts) Description: Proportion of cases with correct subtype (STEMI/NSTEMI/UA/CCS) compared with expert-adjudicated gold standard. | 1 month |
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Inclusion Criteria:Hospital encounters with admission HPI documenting sym
2a4afaef-9dc1-47fc-874f-9dffaf7…
evant to coronary syndrome subtyping.
Cases with sufficient documentation to assign one of four target subtypes (STEMI, NSTEMI, UA, CCS) by adjudication.
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Exclusion Criteria: Unclear subtype or incomplete/uncertain time information preventing gold standard assignment.
Non-CHD primary reason for admission after screening (for MIMIC-IV cohort).
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The study population includes (1) de-identified clinical encounter records and (2) physician participants for usability testing. For record-based cohorts, eligible encounters contain an admission/presentation History of Present Illness (HPI) (text or image-derived text) sufficient for 4-class coronary syndrome subtyping (e.g., STEMI, NSTEMI, unstable angina, chronic coronary syndrome). Records are analyzed at the encounter level and are organized into five dataset-based cohorts (internal validation, multicenter external validation, ED external validation, English EHR external validation, and clinician usability). Reference labels are assigned using a prespecified clinical adjudication process.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojin Gao, Dr | Contact | +86010 88322415 | sophie_gao@sina.com |
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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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| Clinician Usability Cohort | Prospective usability evaluation cohort. Physicians complete a structured coronary syndrome subtyping task using admission HPI cases. Outcomes include diagnostic accuracy and time to completion; within-participant comparisons may be performed between unassisted and tool-assisted conditions as prespecified. |
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| Manual Clinical Data Review | Device | Standard manual process in which experienced clinicians review patient medical records and extract the same prespecified clinical indicators and coronary artery disease categories using routine clinical judgment and documentation review. This manual abstraction serves as the human benchmark for comparing diagnostic accuracy, completeness, and operational efficiency against the automated OCR-Prompt-LLM workflow. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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