Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

NCT ID: NCT00831220

Last Updated: 2009-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-10-31

Brief Summary

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Objective: To investigate the potential role of endothelial dysfunction as a pathogenic mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in patients with COPD, particularly during exacerbations of the disease. Design: prospective and controlled study performed in an university hospital. Population: we compare 4 groups of subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10 smokers or former smokers with normal lung function and 10 never smokers matched by physical activity and BMI. Study variables: a) clinical variables: clinical information, physical examination, pulmonary function tests, ECG and sputum culture; b) Biological variables: number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein, white blood cells), peripheral venous blood test (including hemogram, biochemical analysis with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Endothelial Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with a COPD exacerbation

No interventions assigned to this group

2

Patients with stable COPD

No interventions assigned to this group

3

Smokers or former smokers

No interventions assigned to this group

4

Never smokers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate to very severe COPD admitted in the hospital because of an exacerbation, and,
* Patients with moderate to very severe COPD in stable condition.

Exclusion Criteria

* Patients with an exacerbation of COPD who needed invasive or non invasive mechanical ventilation
* Patients with other chronic inflammatory diseases.
* Patients with other acute or active chronic systemic disease such as heart failure, renal insufficiency, etc.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fondo de Investigacion Sanitaria

OTHER

Sponsor Role collaborator

Hospital Universitari Son Dureta

OTHER

Sponsor Role lead

Responsible Party

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Servei de Pneumologia, Hospital Universitari Son Dureta

Principal Investigators

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Ernest Sala, MD

Role: PRINCIPAL_INVESTIGATOR

Servei de Pneumologia, Hospital Universitari Son Dureta

Locations

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Hospital Universitari Son Dureta

Palma Mallorca, Balearic Islands, Spain

Site Status

Countries

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Spain

Other Identifiers

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PI04/1946

Identifier Type: -

Identifier Source: org_study_id

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