COPD With Coronary Artery CalcificatioNCT07900763
A TwiCs Study of TCM Management Based on Cardiopulmonary Screening in COPD
A study testing TCM-Based Health Management Guided by Coronary Artery Calcium Scores in people with COPD With Coronary Artery Calcificatio, run by Henan University of Traditional Chinese Medicine.
Trial summary
This clinical study seeks to understand whether, for people with stable COPD and coronary artery calcification found on chest CT, adding traditional Chinese medicine (TCM) health guidance (including dietary guidance) based on CT calcification findings to usual care can reduce the chance of developing coronary heart… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- COPD With Coronary Artery Calcificatio
- What is being tested?
- TCM-Based Health Management Guided by Coronary Artery Calcium Scores
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 8 Oct 2027
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stable chronic obstructive pulmonary disease (COPD) and evidence of coronary artery calcification on chest computed tomography, defined as an Agatston score greater than 0.
- Aged 20 to 80 years.
- Willing to comply with the assigned study procedures and provide written informed consent.
- Relatively stable employment, ability to provide detailed contact information, no plans for short-term relocation, and willingness to complete the scheduled follow-up.
Who cannot join
- Established coronary heart disease.
- Pregnancy, breastfeeding, or plans to become pregnant in the near future.
- Impaired consciousness, dementia, or psychiatric disorders.
- Malignancy treated with surgical resection, radiotherapy, or chemotherapy within the previous 5 years.
- Bronchiectasis, active pulmonary tuberculosis, or pulmonary embolism.
- Severe cardiovascular disease, including acute myocardial infarction or cardiac functional class III or higher.
- Severe hepatic or renal disease. Severe hepatic disease includes cirrhosis, portal hypertension, or variceal bleeding. Severe renal disease includes dialysis or renal transplantation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cardiopulmonary Dual Screening and Traditional Chinese Medicine Management Protocol Based on Chest CT Combined With Coronary Artery Calcium Scoring in a COPD Cohort
This clinical study seeks to understand whether, for people with stable COPD and coronary artery calcification found on chest CT, adding traditional Chinese medicine (TCM) health guidance (including dietary guidance) based on CT calcification findings to usual care can reduce the chance of developing coronary heart disease later. The study will also examine its effects on 10-year cardiovascular disease risk, coronary artery calcification score, blood pressure, blood lipids, blood glucose, COPD acute exacerbations, lung function, quality of life, exercise tolerance, symptoms, healthcare costs, and other outcomes.
Researchers will randomly assign participants to two groups and compare:
Read more
Experimental group: usual care + TCM health guidance/dietary guidance Control group: usual care only
Group assignment will be allocated by a third-party system; neither participants nor doctors can choose the group.
Main questions:
Can TCM health guidance reduce the incidence of coronary heart disease, that is, the proportion of participants who develop new coronary heart disease after enrollment? What are its effects on 10-year cardiovascular disease risk, coronary artery calcification score, blood pressure, blood lipids, blood glucose, COPD acute exacerbations, lung function, quality of life, exercise tolerance, symptoms, and health economic indicators? What adverse reactions or discomfort will participants experience?
Participants will:
First complete questionnaires and undergo tests such as lung function and chest CT to determine whether they are eligible; After meeting the criteria and signing the consent form, be randomly assigned to the experimental group or the control group; In the experimental group, receive TCM health guidance/dietary guidance in addition to usual care; the control group will continue usual care only; Undergo routine blood and urine tests, liver and kidney function tests, blood tests, electrocardiogram, chest imaging, lung function tests, and other examinations before the intervention and at 12 months; Have cardiovascular disease risk, COPD acute exacerbations, quality of life, symptoms, blood pressure, blood glucose, blood lipids, exercise tolerance, etc. recorded before the intervention and at 6 and 12 months; Be followed for about 2 years and visit the hospital on time. Who can participate: People aged 20-80 years with a confirmed diagnosis of stable COPD, coronary artery calcification on chest CT (Agatston score > 0), who volunteer to participate and can cooperate with follow-up. People who have existing coronary heart disease, are pregnant or breastfeeding, have severe heart, liver, or kidney disease, active pulmonary tuberculosis, or pulmonary embolism, or have received tumor treatment within the past 5 years, etc., cannot participate.
Costs: The study will pay for study-related examinations such as lung function, routine blood and urine tests, electrocardiogram, liver and kidney function, and chest imaging, and will provide TCM health guidance free of charge. Treatment and tests for other coexisting diseases, and the costs of switching to other treatments because the study treatment is ineffective, are not covered.
Possible benefits: You may experience improvement in your condition and receive good medical care; the results of this study may help doctors find better ways to manage cardiovascular risk in people with COPD. Possible risks: There may be discomfort, changes in your condition, ineffective treatment, inconvenience from traveling to the hospital, or privacy breaches. If you experience any discomfort, tell your doctor promptly. This study has been approved by the Ethics Committee of the First Affiliated Hospital of Henan University of Chinese Medicine.
- Conditions
- COPD With Coronary Artery Calcificatio
- Being tested
- TCM-Based Health Management Guided by Coronary Artery Calcium Scores
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM-Based Health Management Guided by Coronary Artery Calcium ScoresBehavioural
The intervention is a structured traditional Chinese medicine (TCM)-based health management program guided by coronary artery calcium scores. Participants will receive comprehensive dietary guidance incorporating TCM dietary principles and individualized health guidance according to the severity of coronary artery calcification. Recommendations will address cardiovascular risk factors, healthy lifestyle behaviors, and appropriate further cardiovascular evaluation and management according to the coronary artery calcium score. The intervention will be provided throughout the 12-month study period.
| Study group | Role | What they receive |
|---|---|---|
| No TCM-Based Health Management Group | No intervention | Participants randomized to this group will not receive the TCM-based health management intervention guided by coronary artery calcium scores during the 12-month study period. Only scheduled outcome assessments and data collection will be performed. |
| TCM-Based Health Management Group | Experimental | Participants randomized to this group will receive the TCM-based health management intervention guided by coronary artery calcium scores during the 12-month study period. Receives: Behavioral: TCM-Based Health Management Guided by Coronary Artery Calcium Scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Developing Coronary Heart Disease
Measured: From randomization through Month 12
Secondary outcomes (22)
Estimated 10-Year Cardiovascular Disease Risk Using the China-PAR Model
The estimated 10-year risk of cardiovascular disease will be calculated using the China-PAR risk assessment model.
Measured: Baseline and Months 3，6, 9 and 12
Coronary Artery Calcium Score Assessed Using the Agatston Method
Coronary artery calcification will be quantified from chest CT images using the Agatston scoring method.
Measured: Baseline and Months 12
Office Systolic Blood Pressure
Office systolic blood pressure will be measured in millimeters of mercury according to the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 revision).
Measured: Baseline and Months 3, 6, 9, and 12
Office Diastolic Blood Pressure
Office diastolic blood pressure will be measured in millimeters of mercury according to the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 revision).
Measured: Baseline and Months 3, 6, 9, and 12
Proportion of Participants Experiencing at Least One COPD Exacerbation
The proportion of participants experiencing at least one COPD exacerbation during follow-up. Two exacerbations occurring within an interval of 5 days will be counted as one exacerbation.
Measured: From randomization through Month 12; evaluated at Months 6, 12
Severity of COPD Exacerbations
Each COPD exacerbation will be classified as mild, moderate, or severe. Mild exacerbations are worsening respiratory symptoms controlled by increased medication use. Moderate exacerbations require systemic corticosteroids and/or antibiotics. Severe exacerbations require hospitalization or emergency department treatment.
Measured: From randomization through Month 12; evaluated at Months 6, and 12
Duration of COPD Exacerbations
The duration of each COPD exacerbation will be measured in days from the onset of exacerbation symptoms to clinical stabilization.
Measured: From randomization through Month 12; evaluated at Months 6, 12
Forced Vital Capacity
Forced vital capacity will be measured by spirometry.
Measured: Baseline and Months 6 and 12
Forced Expiratory Volume in 1 Second
Forced expiratory volume in 1 second will be measured by spirometry.
Measured: Baseline and Months 6 and 12
FEV1 Percent Predicted
Forced expiratory volume in 1 second expressed as a percentage of the predicted value will be measured by spirometry.
Measured: Baseline and Months 6 and 12
FEV1/FVC Ratio
The ratio of forced expiratory volume in 1 second to forced vital capacity will be calculated from spirometry measurements.
Measured: Baseline and Months 6 and 12
COPD Assessment Test Score
COPD-related health status will be assessed using the COPD Assessment Test.
Measured: Baseline and Months 3, 6, 9, and 12
Health-Related Quality of Life Assessed by the SF-36
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey.
Measured: Baseline and Months 3, 6, 9, and 12
Health Status Assessed by the EQ-5D
Health status will be assessed using the EuroQol 5-Dimension questionnaire.
Measured: Baseline and Months 3, 6, 9, and 12
Health Status Assessed by the Seattle Angina Questionnaire
Angina-related health status and quality of life will be assessed using the Seattle Angina Questionnaire.
Measured: Baseline and Months 3, 6, 9, and 12
Six-Minute Walk Distance
Exercise capacity will be assessed as the distance walked during the six-minute walk test.
Measured: Baseline and Months 3, 6, 9, and 12
Clinical Symptom and Sign Questionnaire Score
Clinical symptoms and signs will be assessed using the study-specific clinical symptom and sign questionnaire.
Measured: Baseline and Months 3, 6, 9, and 12
Modified Medical Research Council Dyspnea Score
Dyspnea severity will be assessed using the modified Medical Research Council dyspnea scale.
Measured: Baseline and Months 3, 6, 9, and 12
CT-Derived Lung Volume
Lung volume will be quantitatively evaluated using chest CT images according to the study imaging protocol.
Measured: Baseline and Months 12
CT-Derived Airway Measurements
Airway characteristics will be quantitatively evaluated using chest CT images according to the study imaging protocol.
Measured: Baseline and Months 12
CT-Derived Pulmonary Vascular Measurements
Pulmonary vascular characteristics will be quantitatively evaluated using chest CT images according to the study imaging protocol.
Measured: Baseline and Months 12
Emphysema Index Assessed by Chest CT
Emphysema index will be evaluated using chest CT images according to the study imaging protocol.
Measured: Baseline and Months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion8 Oct 2027 (estimated)
- Study completion8 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD With Coronary Artery CalcificatioStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900763
- Sponsor's protocol ID
- 2025HL-435
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Dual Screening and Traditional Chinese Medicine Management Protocol Based on Chest CT Combined With Coronary Artery Calcium Scoring in a COPD Cohort
- ClinicalTrials.gov ID
- NCT07900763
- Acronym / sponsor ID
- 2025HL-435
- Conditions
- COPD With Coronary Artery Calcificatio
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 8 Oct 2027 (estimated)
- Study completion
- 8 Oct 2027 (estimated)
- First posted
- 28 Oct 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 clinical study seeks to understand whether, for people with stable COPD and coronary artery calcification found on chest CT, adding traditional Chinese medicine (TCM) health guidance (including dietary guidance) based on CT calcification findings to usual care can reduce the chance of developing coronary heart disease later. The study will also examine its effects on 10-year cardiovascular disease risk, coronary artery calcification score, blood pressure, blood lipids, blood glucose, COPD acute exacerbations, lung function, quality of life, exercise tolerance, symptoms, healthcare costs, and other outcomes.
Researchers will randomly assign participants to two groups and compare:
Experimental group: usual care + TCM health guidance/dietary guidance Control group: usual care only
Group assignment will be allocated by a third-party system; neither participants nor doctors can choose the group.
Main questions:
Can TCM health guidance reduce the incidence of coronary heart disease, that is, the proportion of participants who develop new coronary heart disease after enrollment? What are its effects on 10-year cardiovascular disease risk, coronary artery calcification score, blood pressure, blood lipids, blood glucose, COPD acute exacerbations, lung function, quality of life, exercise tolerance, symptoms, and health economic indicators? What adverse reactions or discomfort will participants experience?
Participants will:
First complete questionnaires and undergo tests such as lung function and chest CT to determine whether they are eligible; After meeting the criteria and signing the consent form, be randomly assigned to the experimental group or the control group; In the experimental group, receive TCM health guidance/dietary guidance in addition to usual care; the control group will continue usual care only; Undergo routine blood and urine tests, liver and kidney function tests, blood tests, electrocardiogram, chest imaging, lung function tests, and other examinations before the intervention and at 12 months; Have cardiovascular disease risk, COPD acute exacerbations, quality of life, symptoms, blood pressure, blood glucose, blood lipids, exercise tolerance, etc. recorded before the intervention and at 6 and 12 months; Be followed for about 2 years and visit the hospital on time. Who can participate: People aged 20-80 years with a confirmed diagnosis of stable COPD, coronary artery calcification on chest CT (Agatston score > 0), who volunteer to participate and can cooperate with follow-up. People who have existing coronary heart disease, are pregnant or breastfeeding, have severe heart, liver, or kidney disease, active pulmonary tuberculosis, or pulmonary embolism, or have received tumor treatment within the past 5 years, etc., cannot participate.
Costs: The study will pay for study-related examinations such as lung function, routine blood and urine tests, electrocardiogram, liver and kidney function, and chest imaging, and will provide TCM health guidance free of charge. Treatment and tests for other coexisting diseases, and the costs of switching to other treatments because the study treatment is ineffective, are not covered.
Possible benefits: You may experience improvement in your condition and receive good medical care; the results of this study may help doctors find better ways to manage cardiovascular risk in people with COPD. Possible risks: There may be discomfort, changes in your condition, ineffective treatment, inconvenience from traveling to the hospital, or privacy breaches. If you experience any discomfort, tell your doctor promptly. This study has been approved by the Ethics Committee of the First Affiliated Hospital of Henan University of Chinese Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No TCM-Based Health Management Group | No intervention | –Participants randomized to this group will not receive the TCM-based health management intervention guided by coronary artery calcium scores during the 12-month study period. Only scheduled outcome assessments and data collection will be performed. |
| TCM-Based Health Management Group | Experimental | Behavioral: TCM-Based Health Management Guided by Coronary Artery Calcium ScoresParticipants randomized to this group will receive the TCM-based health management intervention guided by coronary artery calcium scores during the 12-month study period. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of stable chronic obstructive pulmonary disease (COPD) and evidence of coronary artery calcification on chest computed tomography, defined as an Agatston score greater than 0.
- Aged 20 to 80 years.
- Willing to comply with the assigned study procedures and provide written informed consent.
- Relatively stable employment, ability to provide detailed contact information, no plans for short-term relocation, and willingness to complete the scheduled follow-up.
Key exclusion criteria (7 listed)
- Established coronary heart disease.
- Pregnancy, breastfeeding, or plans to become pregnant in the near future.
- Impaired consciousness, dementia, or psychiatric disorders.
- Malignancy treated with surgical resection, radiotherapy, or chemotherapy within the previous 5 years.
- Bronchiectasis, active pulmonary tuberculosis, or pulmonary embolism.
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 |
|---|---|---|
| TCM-Based Health Management Guided by Coronary Artery Calcium ScoresThe intervention is a structured traditional Chinese medicine (TCM)-based health management program guided by coronary artery calcium scores. Participants will receive comprehensive dietary guidance incorporating TCM dietary principles and individualized health guidance according to the severity of coronary artery calcification. Recommendations will address cardiovascular risk factors, healthy lifestyle behaviors, and appropriate further cardiovascular evaluation and management according to the coronary artery calcium score. The intervention will be provided throughout the 12-month study period. | Behavioural | TCM-Based Health Management Group |
Primary outcome
Proportion of Participants Developing Coronary Heart Disease
Time frame: From randomization through Month 12
22 secondary outcomes
Estimated 10-Year Cardiovascular Disease Risk Using the China-PAR Model
Time frame: Baseline and Months 3，6, 9 and 12
Coronary Artery Calcium Score Assessed Using the Agatston Method
Time frame: Baseline and Months 12
Office Systolic Blood Pressure
Time frame: Baseline and Months 3, 6, 9, and 12
Office Diastolic Blood Pressure
Time frame: Baseline and Months 3, 6, 9, and 12
Proportion of Participants Experiencing at Least One COPD Exacerbation
Time frame: From randomization through Month 12; evaluated at Months 6, 12
Severity of COPD Exacerbations
Time frame: From randomization through Month 12; evaluated at Months 6, and 12
Duration of COPD Exacerbations
Time frame: From randomization through Month 12; evaluated at Months 6, 12
Forced Vital Capacity
Time frame: Baseline and Months 6 and 12
Forced Expiratory Volume in 1 Second
Time frame: Baseline and Months 6 and 12
FEV1 Percent Predicted
Time frame: Baseline and Months 6 and 12
FEV1/FVC Ratio
Time frame: Baseline and Months 6 and 12
COPD Assessment Test Score
Time frame: Baseline and Months 3, 6, 9, and 12
Health-Related Quality of Life Assessed by the SF-36
Time frame: Baseline and Months 3, 6, 9, and 12
Health Status Assessed by the EQ-5D
Time frame: Baseline and Months 3, 6, 9, and 12
Health Status Assessed by the Seattle Angina Questionnaire
Time frame: Baseline and Months 3, 6, 9, and 12
Six-Minute Walk Distance
Time frame: Baseline and Months 3, 6, 9, and 12
Clinical Symptom and Sign Questionnaire Score
Time frame: Baseline and Months 3, 6, 9, and 12
Modified Medical Research Council Dyspnea Score
Time frame: Baseline and Months 3, 6, 9, and 12
CT-Derived Lung Volume
Time frame: Baseline and Months 12
CT-Derived Airway Measurements
Time frame: Baseline and Months 12
CT-Derived Pulmonary Vascular Measurements
Time frame: Baseline and Months 12
Emphysema Index Assessed by Chest CT
Time frame: Baseline and Months 12
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing TCM-Based Health Management Guided by Coronary Artery Calcium Scores in people with COPD With Coronary Artery Calcificatio, run by Henan University of Traditional Chinese Medicine.
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 4 inclusion and 7 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yang Xie, Doctor (China: 13526621325, xieyanghn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Developing Coronary Heart Disease (time frame: From randomization through Month 12). 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 28 Oct 2026.