Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 767
- 试验地点
- 1
- 主要终点
- Aortic Pulse Wave Velocity (arterial stiffness)
研究概览
简要总结
Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular disease is a major cause of death in such patients and it may be related to excess stiffening of the walls of major arteries, such as the aorta, and it has been suggested to represent premature aging. However, there is little known of the development of these problems, which were previously considered to be due to smoking and which is now known not to be the only factor. The investigators will study a large group of patients with mild to very severe airflow obstruction based on the NICE 2010 classification of severity and a matched comparator group free of COPD. This study involves three assessments of the development of the complications of COPD over a five year period. The key measure will be the rate of change in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in wall stiffness will be related to the severity of lung disease; other known cardiovascular risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular events including heart attacks and death; and to the presence of other complications, such as osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the context of changes in bodywide inflammation and metabolic function and the changes in the rate of ageing. This increased knowledge of interacting factors in the complications of COPD is likely to lead to studies of treatments to avoid their development.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously Proven COPD or at risk of developing COPD
排除标准
- •Pregnancy
- •A history of malignancy in the last 5 years
- •Unable to give informed consent or diagnosed dementia
- •Renal or hepatic failure
- •Active endocrine disorder eg., Addison's disease, hypothyroidism
- •Any other disease identified as having an inflammatory or metabolic component, eg. rheumatoid disease
- •Disorders affecting mobility, eg. Parkinson's disease, cerebrovascular accident.
结局指标
主要结局
Aortic Pulse Wave Velocity (arterial stiffness)
时间窗: Baseline, 2 and 5 yrs
Rate of change in aortic pulse wave velocity in patients with COPD over a period of 5 years and its relationship to cardiovascular morbidity and mortality.
次要结局
未报告次要终点
