ClinicalTrials.gg
CompletedNCT07449429OCR-LLM-CHDUpdated Oct 27, 2026

AI-Assisted Coronary Syndrome Subtyping From Admission History of Present Illness: A Clinician Reader Study

An observational study in Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Acute Coronary Syndromes and ST-segment Elevation Myocardial Infarction (STEMI), sponsored by China National Center for Cardiovascular Diseases. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by China National Center for Cardiovascular Diseases · Observational

Updated Oct 27, 2026Now CompletedFirst site in China+4 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases — 26 open to participants now, 27 under way, none of them phase 3. Coronary Artery Disease · China National Center for Cardiovascular Diseases.

Enrollment
25th of 25
10 · median 460
Started
2026
with 10 others
Observational
25 of 57
9 open now
Registered
48th of 57
by date

Among the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases, this one is the 25th largest by enrollment of the 25 observational ones that give a count, is one of 11 that started in 2026, is one of 25 observational ones, and was the 48th registered.

Coronary Artery Disease

4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

26 of the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases are open now, in 1 country. Recruiting first, the newest first:

21 more — sign in →

By country, each count listing its studies:

All 26 open studies →

Where they have run

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 403 (69%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 18 Years and older · all sexes.

The full table on the hub →

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02

Study summary

This study will evaluate whether an OCR-LLM-based clinical decision support framework improves clinicians' accuracy in classifying coronary syndrome subtypes from admission history of present illness. Participating clinicians will classify a set of cases first without AI assistance and then with assistance from the OCR-LLM framework. The primary outcome is the change in classification accuracy between unaided and AI-assisted assessments.

03

Conditions studied

  • Coronary 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)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study 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.

Eligibility criteria

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.

-

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).

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM) · Device: Manual Clinical Data Review

Interventions

  • DeviceOCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM)

    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.

  • DeviceManual Clinical Data Review

    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.

06

What researchers measure

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.

    Time frame: 1 month

07

Study locations

1 site
  • Fuwai Hospital
    Beijing, China
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2026 to primary completion in Mar 2026, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2026
First posted
Mar 4, 2026
StartActual
Feb 28, 2026
Primary completionActual
Mar 8, 2026
CompletionActual
Mar 8, 2026
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Oct 27, 2026
Sites
1 site added — first site in China
Show site
  • Fuwai Hospital · Beijing, China
Oct 27, 2026
Interventions
Arms removed: Internal Development and Validation Cohort·Multicenter External Validation Cohort·Emergency Department External Validation Cohort·English EHR External Validation Cohort
Oct 27, 2026
Title
A Privacy-Preserving OCR-LLM System for Coronary Syndrome Subtyping From Admission HPI: Multicenter Validation in China and the US→AI-Assisted Coronary Syndrome Subtyping From Admission History of Present Illness: A Clinician Reader Study
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Not yet recruiting→Completed
    1 site added — first site in China
    Show site
    • Fuwai Hospital · Beijing, China
    Interventions Arms removed: Internal Development and Validation Cohort·Multicenter External Validation Cohort·Emergency Department External Validation Cohort·English EHR External Validation Cohort
    Title A Privacy-Preserving OCR-LLM System for Coronary Syndrome Subtyping From Admission HPI: Multicenter Validation in China and the US→AI-Assisted Coronary Syndrome Subtyping From Admission History of Present Illness: A Clinician Reader Study
    + 3 other changes: date precision, description and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07449429
Responsible party
Sponsor
First posted
Mar 4, 2026
Start date
Feb 28, 2026
Primary completion
Mar 8, 2026
Completion
Mar 8, 2026
Last update
Oct 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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