Clinical Research Directory

A TwiCs Study of TCM Management Based on Cardiopulmonary Screening in COPD

Sponsor: Henan University of Traditional Chinese Medicine

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 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.

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

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