A Privacy-Preserving OCR-LLM System for Coronary Syndrome Subtyping From Admission HPI: Multicenter Validation in China and the US
OCR-LLM-CHD
Development and Multicenter Validation of a Privacy-Preserving OCR-LLM Pipeline for Four-Subtype Coronary Syndrome Classification Using Admission HPI Across Heterogeneous EHR Systems
2 other identifiers
observational
10
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2026
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
February 27, 2026
CompletedStudy Start
First participant enrolled
February 28, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2026
CompletedMarch 4, 2026
February 1, 2026
8 days
February 27, 2026
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (5)
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).
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.
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.
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).
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.
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- a4afaef-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.
You may not qualify if:
- Non-CHD primary reason for admission after screening (for MIMIC-IV cohort).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 4, 2026
Study Start
February 28, 2026
Primary Completion
March 8, 2026
Study Completion
March 8, 2026
Last Updated
March 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.