Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
EDAECOPD
Endothelial Dysfunction and Systemic Inflammation in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
1 other identifier
observational
29
1 country
1
Brief Summary
The purpose of the study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2008
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
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedMarch 12, 2014
March 1, 2014
2.1 years
October 25, 2011
March 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of endothelial dysfunction (impaired vasomotor reactivity due to shaer stress) confirmed by non-invasive measurement of flow mediated dilation (FMD) 6-8 weeks after acute exacerbation of COPD
Baseline, Week 6-8
Secondary Outcomes (1)
change of systemic inflammation 6-8 weeks after COPD-exacerbation confirmed by inflammatory markers such as interleukin-6 (IL-6), fibrinogen levels, and C-reactive protein (CRP) levels
baseline, week 6-8
Study Arms (1)
Exacerbation
The study sample will consist of patients admitted to the hospital because of an acute exacerbation of COPD
Eligibility Criteria
Patients with COPD diagnosed according to standard criteria in the state of acute exacerbation
You may qualify if:
- presence of COPD according to standard criteria
- acute exacerbation of COPD according to recommended international criteria
- over 40 years of age
- history of at least 10 py
You may not qualify if:
- pneumonia
- history or signs of congestive heart failure,
- acute myocardial infarction
- thoracotomy incl. resection of lungtissue
- interstitial lung disease
- acute or chronic renal failure
- active malignancy
- autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1.Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital
Vienna, Vienna, 1140, Austria
Biospecimen
Serum, Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georg C Funk, M.D.
1. Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital, Vienna, Austria
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Study coordinator
Study Record Dates
First Submitted
October 25, 2011
First Posted
October 26, 2011
Study Start
August 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
March 12, 2014
Record last verified: 2014-03