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COPD and Cardiovascular Risk in the Population (CORSAIB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00787748
First Posted: November 7, 2008
Last Update Posted: June 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Cimera
  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

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 ]

Secondary Outcome Measures:
  • Underdiagnosis of COPD [ Time Frame: Current ]
  • Undertreatment of COPD [ Time Frame: Current ]

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)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787748


Locations
Spain
CIMERA
Bunola, Illes Balears, Spain, 07110
Sponsors and Collaborators
Cimera
Fondo de Investigacion Sanitaria
Investigators
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
First Submitted: November 6, 2008
First Posted: November 7, 2008
Last Update Posted: June 15, 2012
Last Verified: June 2012

Keywords provided by Cimera:
Cardiovascular
COPD
Population
Prevalence
Underdiagnosis

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