- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00831220
Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease
January 27, 2009 updated by: Hospital Universitari Son Dureta
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
99
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
-
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Illes Balears
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Palma Mallorca, Illes Balears, Spain, 07014
- Hospital Universitari Son Dureta
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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
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Patients with an exacerbation of COPD admitted to our hospital, stable COPD recruited in an ambulatory basis, smokers or former smokers and never smokers recruited in our laboratory.
Description
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.
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
1
Patients with a COPD exacerbation
|
2
Patients with stable COPD
|
3
Smokers or former smokers
|
4
Never smokers
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ernest Sala, MD, Servei de Pneumologia, Hospital Universitari Son Dureta
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
March 1, 2005
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
January 27, 2009
First Submitted That Met QC Criteria
January 27, 2009
First Posted (Estimate)
January 28, 2009
Study Record Updates
Last Update Posted (Estimate)
January 28, 2009
Last Update Submitted That Met QC Criteria
January 27, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI04/1946
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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