Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier:
NCT00831220
First received: January 27, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease
Endothelial Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Son Dureta:

Biospecimen Retention:   Samples Without DNA

Plasma and serum.


Enrollment: 99
Study Start Date: March 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with a COPD exacerbation
2
Patients with stable COPD
3
Smokers or former smokers
4
Never smokers

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831220

Locations
Spain
Hospital Universitari Son Dureta
Palma Mallorca, Illes Balears, Spain, 07014
Sponsors and Collaborators
Hospital Universitari Son Dureta
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Ernest Sala, MD Servei de Pneumologia, Hospital Universitari Son Dureta
  More Information

No publications provided

Responsible Party: Dr. Ernest Sala, Servei de Pneumologia, Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier: NCT00831220     History of Changes
Other Study ID Numbers: PI04/1946
Study First Received: January 27, 2009
Last Updated: January 27, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitari Son Dureta:
COPD
exacerbations
EPCs
Erythropoietin
C-RP
COPD and endothelial dysfunction

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 02, 2014