NCT00831220

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

2.6 years

First QC Date

January 27, 2009

Last Update Submit

January 27, 2009

Conditions

Keywords

COPDexacerbationsEPCsErythropoietinC-RPCOPD and endothelial dysfunction

Study Arms (4)

1

Patients with a COPD exacerbation

2

Patients with stable COPD

3

Smokers or former smokers

4

Never smokers

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Study Sites (1)

Hospital Universitari Son Dureta

Palma Mallorca, Balearic Islands, 07014, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ernest Sala, MD

    Servei de Pneumologia, Hospital Universitari Son Dureta

    PRINCIPAL INVESTIGATOR

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

Locations