Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Cardiff University.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

Resource links provided by NLM:


Further study details as provided by Cardiff University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 750
Study Start Date: May 2011
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656421

Contacts
Contact: Nichola S Gale, PhD, BSc +44 (0) 29202352 galens@cardiff.ac.uk
Contact: Margaret Munnery +44 (0) 29202352 MunneryMM1@cardiff.ac.uk

Locations
United Kingdom
Wales Heart Research Institute Recruiting
Cardiff, United Kingdom, CF14 4XN
Contact: Nichola S Gale, BSc, PhD    +44 (0) 2920742352    galens@cardiff.ac.uk   
Contact: Margaret Munnery    +44 (0) 2920742352    munnerymm1@cardiff.ac.uk   
Sponsors and Collaborators
Cardiff University
GlaxoSmithKline
Investigators
Principal Investigator: Dennis J Shale, MD, FRCP Cardiff University
Principal Investigator: John R Cockcroft, MD, FRCP Cardiff University
  More Information

No publications provided

Responsible Party: Nichola Gale, Research Associate, Cardiff University
ClinicalTrials.gov Identifier: NCT01656421     History of Changes
Other Study ID Numbers: SPON 87610, 10/CAD/4972
Study First Received: August 1, 2012
Last Updated: August 2, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014