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Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

NCT ID: NCT02092675

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.

Detailed Description

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Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in developed countries. Acute exacerbations and cardiovascular diseases are the major causes of morbidity and mortality in COPD patients. According to the frequency of exacerbations, phenotype "frequent exacerbator" is defined and characterised with severe clinical course and was recognised as an increased risk for cardiovascular mortality. Recent studies considered that systemic inflammation plays a key role in the pathogenesis of COPD and endothelial dysfunction is a suspected link between increased cardiovascular mortality and systemic inflammation in COPD patients. Endothelial dysfunction is assessed by determining flow mediated dilatation index (FMD index) or plasma markers. Previous studies have suggested the presence of endothelial dysfunction in COPD patients, as well as the deterioration of endothelial function during exacerbations of COPD. This study will, for the first time, systematically explore endothelial dysfunction in two phenotypically distinct groups of COPD patients with simultaneous assessment of endothelial function flow mediated dilatation index (FMD index) and plasma markers.

Conditions

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Chronic Obstructive Pulmonary Disease Endothelial Dysfunction

Keywords

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Chronic obstructive pulmonary disease frequent exacerbator endothelial dysfunction Flow mediated dilatation Systemic inflammation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD patients - frequent exacerbator

COPD patients with 2 and more exacerbation in one year

No interventions assigned to this group

COPD patients - non frequent exacerbator

COPD patients with less than 2 exacerbation during one year

No interventions assigned to this group

control group - healthy smokers

healthy smokers, they do not have COPD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* COPD patients in stable condition ( without exacerbation min 1 months ago)
* Over 40 years
* History of at least 10 py

Exclusion Criteria

* acute exacerbation of COPD
* active malignancy
* autoimmune disease
* acute myocardial infarction
* diabetes mellitus with late complications
* congestive heart failure
* women of childbearing potential
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Andrea Vukic Dugac

OTHER

Sponsor Role lead

Responsible Party

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Andrea Vukic Dugac

pulmonary disease specialist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrea Vukic Dugac

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zagreb

Locations

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Univerity Hospital Centre Zagreb

Zagreb, Croatia, Croatia

Site Status

Countries

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Croatia

Other Identifiers

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ED-1971-UHCZ

Identifier Type: OTHER

Identifier Source: secondary_id

ED-1971-HR

Identifier Type: -

Identifier Source: org_study_id