NCT00787748

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
623

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

1.7 years

First QC Date

November 6, 2008

Last Update Submit

June 14, 2012

Conditions

Chronic Obstructive Pulmonary DiseaseCardiovascular Disease

Keywords

CardiovascularCOPDPopulationPrevalenceUnderdiagnosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Current

Secondary Outcomes (2)

  • Underdiagnosis of COPD

    Current

  • Undertreatment of COPD

    Current

Eligibility Criteria

Age40 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Random population sample, and a sample of hospital cardiovascular patients

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIMERA

Bunola, Balearic Islands, 07110, Spain

Location

Related Publications (1)

  • Soriano JB, Rigo F, Guerrero D, Yanez A, Forteza JF, Frontera G, Togores B, Agusti A. High prevalence of undiagnosed airflow limitation in patients with cardiovascular disease. Chest. 2010 Feb;137(2):333-40. doi: 10.1378/chest.09-1264. Epub 2009 Sep 25.

    PMID: 19783666RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of serum were frozen at -80 ºC

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCardiovascular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fernando Rigo, MD

    Atención Primaria de Mallorca

    STUDY DIRECTOR

  • Alvar Agusti, MD

    Cimera

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

ES(1)