Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))OCR-LLM-CHDNCT07449429
AI-Assisted Coronary Syndrome Subtyping From Admission History of Present Illness: A Clinician Reader Study
An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Acute Coronary Syndromes, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Acute Coronary Syndromes, ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM) and Manual Clinical Data Review
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 8 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Inclusion Criteria:Hospital encounters with admission HPI documenting sym
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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).
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinician Reader Study Evaluating an OCR-LLM Framework for Coronary Syndrome Subtyping From Admission History of Present Illness
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.
- Conditions
- 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)
- Being tested
- OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM), Manual Clinical Data Review
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction, Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ReviewDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM); Device: Manual Clinical Data Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start28 Feb 2026
- Primary completion8 Mar 2026
- Study completion8 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449429
- Sponsor's protocol ID
- CAD-LLM-002
- Other IDs
- Sponsor
- Acronym
- OCR-LLM-CHD
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinician Reader Study Evaluating an OCR-LLM Framework for Coronary Syndrome Subtyping From Admission History of Present Illness
- ClinicalTrials.gov ID
- NCT07449429
- Acronym / sponsor ID
- OCR-LLM-CHD / CAD-LLM-002
- Conditions
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 8 Mar 2026 (actual)
- Study completion
- 8 Mar 2026 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinician Usability Cohort | – | Device: OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM), Device: Manual Clinical Data ReviewProspective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCR-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. | Device | Clinician Usability Cohort |
| Manual Clinical Data ReviewStandard 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. | Device | Clinician Usability Cohort |
Primary outcome
Overall classification accuracy
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Acute Coronary Syndromes, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall classification accuracy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.