Assessment of Risk in Chronic Airways Disease Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously Proven COPD or at risk of developing COPD Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD<br>Patients with Chronic Obstructive Pulmonary Disease, including mild, moderate, severe and very severe airflow obstruction | |
| Comparators<br>Current or ex-smokers free from from Respiratory Disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic Pulse Wave Velocity (arterial stiffness) | 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. | Baseline, 2 and 5 yrs |