Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease
1 other identifier
observational
99
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2005
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 27, 2009
CompletedFirst Posted
Study publicly available on registry
January 28, 2009
CompletedJanuary 28, 2009
January 1, 2009
2.6 years
January 27, 2009
January 27, 2009
Conditions
Keywords
Study Arms (4)
1
Patients with a COPD exacerbation
2
Patients with stable COPD
3
Smokers or former smokers
4
Never smokers
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitari Son Duretalead
- Fondo de Investigacion Sanitariacollaborator
Study Sites (1)
Hospital Universitari Son Dureta
Palma Mallorca, Balearic Islands, 07014, Spain
Biospecimen
Plasma and serum.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernest Sala, MD
Servei de Pneumologia, Hospital Universitari Son Dureta
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 27, 2009
First Posted
January 28, 2009
Study Start
March 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
January 28, 2009
Record last verified: 2009-01