Clinical trial NCT01656421: Assessment of Risk in Chronic Airways Disease Evaluation
Official title: Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Cardiff University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Cardiff Metropolitan University
First posted: 2012-08-03
Enrollment: 767
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Aortic Pulse Wave Velocity (arterial stiffness)
timeFrame: Baseline, 2 and 5 yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff Metropolitan University
Study officials:
affiliation: Cardiff Metropolitan University
name: Barry J McDonnell, PhD BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff Metropolitan University
name: John R Cockcroft, MD, FRCP
role: STUDY_CHAIR
References:
citation: Mohan D, Forman JR, Allinder M, McEniery CM, Bolton CE, Cockcroft JR, MacNee W, Fuld J, Marchong M, Gale NS, Fisk M, Nagarajan S, Cheriyan J, Lomas DA, Calverley PMA, Miller BE, Tal-Singer R, Wilkinson IB, Polkey MI; ERICA Consortium. Fibrinogen does not relate to cardiovascular or muscle manifestations in COPD: cross-sectional data from the ERICA study. Thorax. 2018 Dec;73(12):1182-1185. doi: 10.1136/thoraxjnl-2018-211556. Epub 2018 Apr 4.
citation: 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.