An interventional study of TCM-Based Health Management Guided by Coronary Artery Calcium Scores in COPD With Coronary Artery Calcificatio, sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Henan University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 200 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 55 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Behavioral: TCM-Based Health Management Guided by Coronary Artery Calcium Scores
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.
Proportion of Participants Developing Coronary Heart Disease
Time frame: From randomization through Month 12
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From randomization through Month 12; evaluated at Months 6, 12
Forced Vital Capacity
Forced vital capacity will be measured by spirometry.
Time frame: Baseline and Months 6 and 12
Forced Expiratory Volume in 1 Second
Forced expiratory volume in 1 second will be measured by spirometry.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Months 6 and 12
COPD Assessment Test Score
COPD-related health status will be assessed using the COPD Assessment Test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Months 12
CT-Derived Airway Measurements
Airway characteristics will be quantitatively evaluated using chest CT images according to the study imaging protocol.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Months 12
Cost-Effectiveness of the TCM-Based Health Management Intervention
Cost-effectiveness will be evaluated by comparing the costs and clinical effects between the two study groups over the 24-month study period.
Time frame: From randomization through Month 12
Cost-Benefit of the TCM-Based Health Management Intervention
Cost-benefit will be evaluated by comparing the costs and monetary benefits between the two study groups over the 24-month study period.
Time frame: From randomization through Month 12
Number and Proportion of Participants With Adverse Events
All adverse events occurring during the study will be recorded, including the type, severity, time of onset, duration, management, and outcome of each event.
Time frame: From randomization through Month 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Henan University of Traditional Chinese Medicine