Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
- 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 |
Community sample
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| 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 | |
| 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 | |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 13, 2013