COPD and Cardiovascular Risk in the Population (CORSAIB)
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Purpose
The prevalence of chronic obstructive pulmonary disease (COPD) in patients with cardiovascular disease (CVD) is unknown, and whether or not COPD is adequately diagnosed and treated in these patients has not been investigated before.
We hypothesized that the prevalence of COPD would be significantly higher (30%) in patients with CVD than in the general population. Besides, we anticipated that COPD, a potentially treatable CV risk factor, would be undiagnosed in more than 80% of CVD patients.
| Condition |
|---|
|
Chronic Obstructive Pulmonary Disease Cardiovascular Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | COPD and Cardiovascular Risk in the Population |
- Prevalence of COPD defined according to the current GOLD guidelines as a post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) <0.7. [ Time Frame: Current ] [ Designated as safety issue: No ]
- Underdiagnosis of COPD [ Time Frame: Current ] [ Designated as safety issue: No ]
- Undertreatment of COPD [ Time Frame: Current ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Samples of serum were frozen at -80 ºC
| Enrollment: | 623 |
| Study Start Date: | October 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
We aim to compare clinical and spirometric data in three groups of individuals. Two of them are participants in an ongoing population-based study (CORSAIB) aimed at investigating the distribution of CVD risk factors in the general population of the Balearic Islands, Spain. The design and full methodological details of the CORSAIB study have been published elsewhere (Rigo F, et al. Rev Clin Espa 2005). A third group will include patients with stable CVD regularly visited at the referral hospital of our community.
Inclusion criteria for the study are male and female individuals, aged 40 to 81 years, residents of the Balearic Islands, and who are willing to participate in this research.
Eligibility| Ages Eligible for Study: | 40 Years to 81 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Random population sample, and a sample of hospital cardiovascular patients
Inclusion Criteria:
- residents of the Balearic Islands
- willing to participate in this research
- able to sign the written consent form
Exclusion Criteria:
- none
Contacts and Locations| Spain | |
| CIMERA | |
| Bunola, Illes Balears, Spain, 07110 | |
| Study Director: | Fernando Rigo, MD | Atención Primaria de Mallorca |
| Study Director: | Alvar Agusti, MD | Cimera |
More Information
Additional Information:
Publications:
| Responsible Party: | Cimera |
| ClinicalTrials.gov Identifier: | NCT00787748 History of Changes |
| Other Study ID Numbers: | PI061228, IB-9949, IB-615/06PI |
| Study First Received: | November 6, 2008 |
| Last Updated: | June 14, 2012 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Cimera:
|
Cardiovascular COPD Population Prevalence Underdiagnosis |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Lung Diseases Respiration Disorders |
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013