Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Study Type: Observational
• Enrollment (Actual): 767

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF5 2YB.
    • Cardiff Metropolitan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aortic Pulse Wave Velocity (arterial stiffness)	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.	Baseline, 2 and 5 yrs

Collaborators and Investigators

• Sponsor: Cardiff University
• Collaborators: GlaxoSmithKline; Cardiff Metropolitan University
• Investigators: Principal Investigator: Barry J McDonnell, PhD BSc, Cardiff Metropolitan University; Study Chair: John R Cockcroft, MD, FRCP, Cardiff Metropolitan University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SPON 87610; 10/CAD/4972 (Other Identifier: Cardiff & Vale UHB R&D Office)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No