COPD and Cardiovascular Risk in the Population - Full Text View

Sponsors and Collaborators:	Fundacion Caubet-Cimera Islas Baleares Fondo de Investigacion Sanitaria Fundació Barceló
Information provided by:	Cimera
ClinicalTrials.gov Identifier:	NCT00787748

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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional
Official Title:	COPD and Cardiovascular Risk in the Population

Further study details as provided by Cimera:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Biospecimen Description:

Samples of serum were frozen at -80 ºC

Enrollment:	623
Study Start Date:	October 2006
Estimated Study Completion Date:	November 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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

Study Population

Random population sample, and a sample of hospital cardiovascular patients

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787748

Locations

Spain, Illes Balears
CIMERA
Bunola, Illes Balears, Spain, 07110

Sponsors and Collaborators

Fundacion Caubet-Cimera Islas Baleares

Fondo de Investigacion Sanitaria

Fundació Barceló

Investigators

Study Director:	Fernando Rigo, MD	Atención Primaria de Mallorca
Study Director:	Alvar Agusti, MD	Cimera

More Information

Web of CIMERA This link exits the ClinicalTrials.gov site

Responsible Party:	CIMERA ( Joan B Soriano )
Study ID Numbers:	PI061228, IB-9949, IB-615/06PI
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00787748
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Cimera:

Cardiovascular
COPD
Population
Prevalence
Underdiagnosis

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009