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COPD and Cardiovascular Risk in the Population (CORSAIB)

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Cimera
ClinicalTrials.gov Identifier:
NCT00787748
First received: November 6, 2008
Last updated: June 14, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


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

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

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

ClinicalTrials.gov processed this record on November 27, 2014