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Completed

NCT Number: NCT01656421

Assessment of Risk in Chronic Airways Disease Evaluation

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.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiff Metropolitan University

Cardiff, CF5 2YB., United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Aortic Pulse Wave Velocity (arterial stiffness)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cardiff University

Other

Collaborators

  • Cardiff Metropolitan University
  • GlaxoSmithKline

Registry information

Official study title

Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

Acronym: ARCADE

Important dates

Study start
2011
Primary completion
2016
Study completion
2019
First posted
Aug 3, 2012
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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