COPD and Cardiovascular Risk in the Population | NCT00787748

Studies
COPD and Cardiovascular Risk in the Population

NCT00787748

Sponsor

Cimera

Status

Completed

Last Update Posted

Jun 15, 2012Estimated

Enrollment

623Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease
Cardiovascular Disease

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Nov 6, 2008

First Submission Date that Met QC Criteria

Nov 6, 2008

First Posted Date

Nov 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2012

Last Update Posted Date

Jun 15, 2012Estimated

Name	Class
Fondo de Investigacion Sanitaria	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

623Actual

Outcomes Module

Primary Outcomes

Measure	Description	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.		Current

Secondary Outcomes

Measure	Description	Time Frame
Underdiagnosis of COPD		Current
Undertreatment of COPD		Current

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

81 Years

Standard Ages

AdultOlder Adult

Study Population

Random population sample, and a sample of hospital cardiovascular patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernando Rigo, MD	Atención Primaria de Mallorca	Study Director
Alvar Agusti, MD	Cimera	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CIMERA		Bunola	Balearic Islands	07110	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19783666	Result	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.

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D002318	Cardiovascular Diseases

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

ID	Type	Description	Link
IB-9949
IB-615/06PI