Dynamic Functional Imaging Phenotyping and Disease Progression Risk Assessment in COPD Using Dynamic Chest Radiography: A Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Exacerbation/respiratory history and event
研究概览
简要总结
To evaluate the utility of DCR-derived parameters for identifying dynamic functional imaging phenotypes, assessing disease severity, and predicting the risk of disease progression in COPD.
详细描述
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. Approximately 100 million people in China have COPD, yet the early diagnosis rate remains below 13%. This multicenter retrospective study will collect previously acquired dynamic chest radiography (DCR) images, pulmonary function test results, chest computed tomography images, symptom scores, clinical data, and follow-up outcomes from participating centers. A standardized multicenter retrospective DCR-COPD database will be established to systematically evaluate the utility of DCR-derived parameters for characterizing dynamic functional imaging phenotypes, assessing disease severity, and predicting the risk of COPD progression. The study will also provide a foundation for model development and subsequent prospective multicenter validation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30-85 years.
- •Male or female.
- •Patients who underwent pulmonary function testing and dynamic chest radiography at the hospital.
排除标准
- •Incomplete medical records.
- •Considered unsuitable for inclusion in the study at the investigator's discretion.
研究组 & 干预措施
COPD group
any patient who complains of dyspnea, chronic cough or sputum, a history of recurrent lower respiratory infection and/or a history of exposure to disease risk factors, Pulmonary function examination indicated that FEV1/FVC <0.7 after bronchodilator was used to confirm COPD.
PRISM group
After bronchial dilation, FEV1/FVC was ≥0.70, and FEV1%PRED was <80%.
Smoking exposure groups
Smoking history of 10 years, or without COPD, pulmonary function of COPD diagnosis standard.
Normal control group
Never-smokers without airflow limitation and with normal pulmonary function.
结局指标
主要结局
Exacerbation/respiratory history and event
时间窗: At Baseline
Measurement of disease control and burden
FEV1 %
时间窗: At Baseline
Measurement of lung function
FEV1 /FVC
时间窗: At Baseline
Measurement of lung function
Emphysema
时间窗: At Baseline
Measurement of chest CT
diaphragm movement
时间窗: At Baseline
Measurement of Dynamic chest radiograph
lung field area
时间窗: At Baseline
Measurement of Dynamic chest radiograph
lung field area change rate
时间窗: At Baseline
Measurement of Dynamic chest radiograph
CAT
时间窗: At Baseline
Measurement of questionnaires
SGRQ
时间窗: At Baseline
Measurement of questionnaires
mMRC
时间窗: At Baseline
Measurement of questionnaires
Smoking history and status
时间窗: At Baseline
Risk factors of COPD development or lung function decline
次要结局
未报告次要终点