A Privacy-Preserving OCR-LLM System for Coronary Syndrome Subtyping From Admission HPI: Multicenter Validation in China and the US

ConditionsCoronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Acute Coronary Syndromes ST-segment Elevation Myocardial Infarction (STEMI)Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

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.
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.

Treatment groups

10 Participants

are divided into 5 treatment groups

Group A: Internal Development and Validation Cohort2 interventions

Group B: Multicenter External Validation Cohort2 interventions

Group C: Emergency Department External Validation Cohort2 interventions

Group D: English EHR External Validation Cohort2 interventions

Group E: Clinician Usability Cohort2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

1 month

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Source ClinicalTrials.gov

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