Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Cardiff University
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Nichola Gale, Cardiff University
ClinicalTrials.gov Identifier:
NCT01656421
First received: August 1, 2012
Last updated: August 2, 2012
Last verified: August 2012

August 1, 2012
August 2, 2012
May 2011
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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 ClinicalTrials.gov 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
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
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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.
Both
35 Years to 80 Years
Yes
Contact: Nichola S Gale, PhD, BSc +44 (0) 29202352 galens@cardiff.ac.uk
Contact: Margaret Munnery +44 (0) 29202352 MunneryMM1@cardiff.ac.uk
United Kingdom
 
NCT01656421
SPON 87610, 10/CAD/4972
No
Nichola Gale, Cardiff University
Cardiff University
GlaxoSmithKline
Principal Investigator: Dennis J Shale, MD, FRCP Cardiff University
Principal Investigator: John R Cockcroft, MD, FRCP Cardiff University
Cardiff University
August 2012

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