Coronary Artery DiseaseNCT07740044
Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management
A study testing Medical large language model in people with Coronary Artery Disease and Atrial Fibrillation (AF), run by Jiangsu Taizhou People's Hospital at 1 site in China.
Trial summary
This study aims to explore the feasibility of using medical large language models to assist in chronic disease management. By setting up experimental and control group interventions and having experts blindly evaluate anonymized cases, it compares different management approaches in chronic disease care, verifying the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation (AF), Heart Failure
- What is being tested?
- Medical large language model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Work experience of 3 years or more;
- Able to complete the case assessment tasks required by the study;
- Have a practicing doctor qualification;
- Work at a township health center or community health service center;
- Voluntarily participate in the study and sign the informed consent form.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Taizhou People's Hospital of Nanjing Medical University
Taizhou, Jiangsu, 225300
Guoyu Wang, MD, +8615951154720, wangguoyutzheart@163.com
About this study
Official title: Verification and Application Study of Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management: A Randomized Controlled Study
This study aims to explore the feasibility of using medical large language models to assist in chronic disease management. By setting up experimental and control group interventions and having experts blindly evaluate anonymized cases, it compares different management approaches in chronic disease care, verifying the scientific basis, effectiveness, and potential for broader use of medical large language models in supporting chronic disease management.
- Being tested
- Medical large language model
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation, Heart Failure, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical large language modelDevice
The primary care physicians in the intervention group completed the management decisions for chronic disease cases, including disease assessment, examination suggestions, treatment plans, selection of management methods, and health education, with the assistance of the medical LLM.
| Study group | Role | What they receive |
|---|---|---|
| LLM-Assisted Intervention Group | Active comparator | Primary care doctors creating management plans for chronic diseases (coronary heart disease, atrial fibrillation, heart failure, stroke) with the help of large medical language models Receives: Device: Medical large language model |
| Usual Care Control Group | No intervention | Primary care doctors creating management plans for chronic diseases (coronary heart disease, atrial fibrillation, heart failure, stroke) without the help of a large medical language model |
What is being measured
The primary outcome is the main question the study is designed to answer.
expert overall scores
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale on several aspects: accuracy of condition assessment, reasonableness of test recommendations, reasonableness of treatment plans, appropriateness of management choices, scientific nature of patient education content, feasibility at the primary care level, overall clinical quality. Experts were instructed to rank the seven dimensions from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
Measured: through study completion, an average of 3 months.
Secondary outcomes (10)
accuracy of condition assessment
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale on accuracy of condition assessment from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
Measured: through study completion, an average of 3 months.
reasonableness of test recommendations
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the reasonableness of test recommendations. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
Measured: through study completion, an average of 3 months.
reasonableness of treatment plans
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the reasonableness of treatment plans. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
Measured: through study completion, an average of 3 months.
appropriateness of management choices
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the ppropriateness of management choices. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
Measured: through study completion, an average of 3 months.
scientific nature of patient education content
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the scientific nature of patient education content. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
Measured: through study completion, an average of 3 months.
feasibility at the primary care level
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the feasibility at the primary care level. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
Measured: through study completion, an average of 3 months.
the overall clinical quality
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the overall clinical quality. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
Measured: through study completion, an average of 3 months.
risk advice
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. If there is no risk advice, the expert selects 'No'; otherwise, the expert selects 'Yes' and specifically lists the content of the risk advice.
Measured: through study completion, an average of 3 months.
Any diagnostic or treatment information missing
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. If there is no omission of diagnostic and treatment information, the expert selects "No"; otherwise, the expert selects "Yes" and specifically lists the omitted diagnostic and treatment content.
Measured: through study completion, an average of 3 months.
feedback regarding the use of medical LLM by primary care physicians
After primary care physicians complete a case assessment assisted by medical LLM , they will fill out an evaluation of the medical LLM usage, including whether the medical LLM helped in disease assessment, assisted in formulating examination plans, aided in developing treatment plans, improved chronic disease management capabilities, supported chronic disease education, assisted in management approach selection, enhanced confidence, saved time, whether there were hallucinations or omissions, whether it provided risky suggestions, and any additional comments on the use of the medical LLM.
Measured: through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start17 Aug 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740044
- Sponsor's protocol ID
- LSKY 2026-114-01
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification and Application Study of Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07740044
- Acronym / sponsor ID
- LSKY 2026-114-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Jul 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 aims to explore the feasibility of using medical large language models to assist in chronic disease management. By setting up experimental and control group interventions and having experts blindly evaluate anonymized cases, it compares different management approaches in chronic disease care, verifying the scientific basis, effectiveness, and potential for broader use of medical large language models in supporting chronic disease management.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM-Assisted Intervention Group | Active comparator | Device: Medical large language modelPrimary care doctors creating management plans for chronic diseases (coronary heart disease, atrial fibrillation, heart failure, stroke) with the help of large medical language models |
| Usual Care Control Group | No intervention | –Primary care doctors creating management plans for chronic diseases (coronary heart disease, atrial fibrillation, heart failure, stroke) without the help of a large medical language model |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Work experience of 3 years or more;
- Able to complete the case assessment tasks required by the study;
- Have a practicing doctor qualification;
- Work at a township health center or community health service center;
- Voluntarily participate in the study and sign the informed consent form.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Medical large language modelThe primary care physicians in the intervention group completed the management decisions for chronic disease cases, including disease assessment, examination suggestions, treatment plans, selection of management methods, and health education, with the assistance of the medical LLM. | Device | LLM-Assisted Intervention Group |
Primary outcome
expert overall scores
Time frame: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale on several aspects: accuracy of condition assessment, reasonableness of test recommendations, reasonableness of treatment plans, appropriateness of management choices, scientific nature of patient education content, feasibility at the primary care level, overall clinical quality. Experts were instructed to rank the seven dimensions from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
10 secondary outcomes
accuracy of condition assessment
Time frame: through study completion, an average of 3 months.
reasonableness of test recommendations
Time frame: through study completion, an average of 3 months.
reasonableness of treatment plans
Time frame: through study completion, an average of 3 months.
appropriateness of management choices
Time frame: through study completion, an average of 3 months.
scientific nature of patient education content
Time frame: through study completion, an average of 3 months.
feasibility at the primary care level
Time frame: through study completion, an average of 3 months.
the overall clinical quality
Time frame: through study completion, an average of 3 months.
risk advice
Time frame: through study completion, an average of 3 months.
Any diagnostic or treatment information missing
Time frame: through study completion, an average of 3 months.
feedback regarding the use of medical LLM by primary care physicians
Time frame: through study completion, an average of 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical large language model in people with Coronary Artery Disease and Atrial Fibrillation (AF), run by Jiangsu Taizhou People's Hospital 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?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 31 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoyu Wang, MD (+8615951154720, wangguoyutzheart@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expert overall scores (time frame: through study completion, an average of 3 months.). 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 31 Jul 2026.