Trial · NCT07900763
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Developing Coronary Heart Disease | From randomization through Month 12 | |
| Secondary | Estimated 10-Year Cardiovascular Disease Risk Using the China-PAR Model | Baseline and Months 3，6, 9 and 12 | The estimated 10-year risk of cardiovascular disease will be calculated using the China-PAR risk assessment model. |
| Secondary | Coronary Artery Calcium Score Assessed Using the Agatston Method | Baseline and Months 12 | Coronary artery calcification will be quantified from chest CT images using the Agatston scoring method. |
| Secondary | Office Systolic Blood Pressure | Baseline and Months 3, 6, 9, and 12 | 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). |
| Secondary | Office Diastolic Blood Pressure | Baseline and Months 3, 6, 9, and 12 | 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). |
| Secondary | Proportion of Participants Experiencing at Least One COPD Exacerbation | From randomization through Month 12; evaluated at Months 6, 12 | 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. |
| Secondary | Severity of COPD Exacerbations | From randomization through Month 12; evaluated at Months 6, and 12 | 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. |
| Secondary | Duration of COPD Exacerbations | From randomization through Month 12; evaluated at Months 6, 12 | The duration of each COPD exacerbation will be measured in days from the onset of exacerbation symptoms to clinical stabilization. |
| Secondary | Forced Vital Capacity | Baseline and Months 6 and 12 | Forced vital capacity will be measured by spirometry. |
| Secondary | Forced Expiratory Volume in 1 Second | Baseline and Months 6 and 12 | Forced expiratory volume in 1 second will be measured by spirometry. |
| Secondary | FEV1 Percent Predicted | Baseline and Months 6 and 12 | Forced expiratory volume in 1 second expressed as a percentage of the predicted value will be measured by spirometry. |
| Secondary | FEV1/FVC Ratio | Baseline and Months 6 and 12 | The ratio of forced expiratory volume in 1 second to forced vital capacity will be calculated from spirometry measurements. |
| Secondary | COPD Assessment Test Score | Baseline and Months 3, 6, 9, and 12 | COPD-related health status will be assessed using the COPD Assessment Test. |
| Secondary | Health-Related Quality of Life Assessed by the SF-36 | Baseline and Months 3, 6, 9, and 12 | Health-related quality of life will be assessed using the 36-Item Short Form Health Survey. |
| Secondary | Health Status Assessed by the EQ-5D | Baseline and Months 3, 6, 9, and 12 | Health status will be assessed using the EuroQol 5-Dimension questionnaire. |
| Secondary | Health Status Assessed by the Seattle Angina Questionnaire | Baseline and Months 3, 6, 9, and 12 | Angina-related health status and quality of life will be assessed using the Seattle Angina Questionnaire. |
| Secondary | Six-Minute Walk Distance | Baseline and Months 3, 6, 9, and 12 | Exercise capacity will be assessed as the distance walked during the six-minute walk test. |
| Secondary | Clinical Symptom and Sign Questionnaire Score | Baseline and Months 3, 6, 9, and 12 | Clinical symptoms and signs will be assessed using the study-specific clinical symptom and sign questionnaire. |
| Secondary | Modified Medical Research Council Dyspnea Score | Baseline and Months 3, 6, 9, and 12 | Dyspnea severity will be assessed using the modified Medical Research Council dyspnea scale. |
| Secondary | CT-Derived Lung Volume | Baseline and Months 12 | Lung volume will be quantitatively evaluated using chest CT images according to the study imaging protocol. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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