COPD and Cardiovascular Risk in the Population

Chronic Obstructive Pulmonary Disease Clinical Trial

— CORSAIB  

Official title:

COPD and Cardiovascular Risk in the Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787748
• Other study ID #: PI061228
• Secondary ID: IB-9949IB-615/06
• Status: Completed
• Phase: N/A
• First received: November 6, 2008
• Last updated: June 14, 2012
• Start date: October 2006
• Est. completion date: June 2008

Study information

• Verified date: June 2012
• Source: Cimera
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 81 Years

Eligibility

Inclusion Criteria:

• residents of the Balearic Islands

• willing to participate in this research

• able to sign the written consent form

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	CIMERA	Bunola	Illes Balears

Sponsors (2)

Lead Sponsor	Collaborator
Cimera	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Soriano JB, Rigo F, Guerrero D, Yañez A, Forteza JF, Frontera G, Togores B, Agustí 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Underdiagnosis of COPD		Current	No
Secondary	Undertreatment of COPD		Current	No

External Links

•   Web of CIMERA