Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01656421
Recruitment Status : Unknown
Verified July 2015 by Nichola Gale, Cardiff University.
Recruitment status was:  Active, not recruiting
First Posted : August 3, 2012
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):
Nichola Gale, Cardiff University

August 1, 2012
August 3, 2012
July 28, 2015
May 2011
December 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01656421 on Archive Site
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Assessment of Risk in Chronic Airways Disease Evaluation
Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)
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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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Community sample
Chronic Obstructive Pulmonary Disease (COPD)
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  • COPD
    Patients with Chronic Obstructive Pulmonary Disease, including mild, moderate, severe and very severe airflow obstruction
  • Comparators
    Current or ex-smokers free from from Respiratory Disease
Gale NS, Albarrati AM, Munnery MM, Munnery IC, Irfan M, Bolton CE, Rambaran CN, Singer RM, Cockcroft JR, Shale DJ. Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE): Protocol and preliminary data. Chron Respir Dis. 2014 Nov;11(4):199-207. doi: 10.1177/1479972314546765. Epub 2014 Aug 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2017
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
SPON 87610
10/CAD/4972 ( Other Identifier: Cardiff & Vale UHB R&D Office )
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Nichola Gale, Cardiff University
Cardiff University
Principal Investigator: Dennis J Shale, MD, FRCP Cardiff University
Principal Investigator: John R Cockcroft, MD, FRCP Cardiff University
Cardiff University
July 2015