Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Nichola Gale, Cardiff University Identifier:
First received: August 1, 2012
Last updated: July 27, 2015
Last verified: July 2015

August 1, 2012
July 27, 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 ] [ Designated as safety issue: No ]
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.
Active, not recruiting
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.
35 Years to 80 Years
Contact information is only displayed when the study is recruiting subjects
United Kingdom
SPON 87610, 10/CAD/4972
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP