COPD and Cardiovascular Risk in the Population (CORSAIB)

June 14, 2012 updated by: Cimera

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

623

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Random population sample, and a sample of hospital cardiovascular patients

Description

Inclusion Criteria:

  • residents of the Balearic Islands
  • willing to participate in this research
  • able to sign the written consent form

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Current

Secondary Outcome Measures

Outcome Measure
Time Frame
Underdiagnosis of COPD
Time Frame: Current
Current
Undertreatment of COPD
Time Frame: Current
Current

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cimera

Collaborators

Fondo de Investigacion Sanitaria

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 6, 2008

First Submitted That Met QC Criteria

November 6, 2008

First Posted (Estimate)

November 7, 2008

Study Record Updates

Last Update Posted (Estimate)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI061228
  • IB-9949
  • IB-615/06PI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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