Neutrophil Gelatinase-associated Lipocalin Concentration in Coronary Artery Disease

NCT ID: NCT00749281

Last Updated: 2010-07-08

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

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

Brief Summary

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Serum NGAL has been described as a biomarker of neutrophil activation and an inflammatory marker which correlates to obesity and its metabolic complications. Since neutrophil activation has been implicated in the pathogenesis of coronary artery disease, the investigators hypothesized that serum NGAL levels would be higher in patients with CAD and that serum concentration would correlate with the extent of CAD as documented by coronary angiography, serving as a potential biomarker of the severity of CAD.

Detailed Description

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Inflammation is considered to play a major role in coronary artery disease (CAD) which accounts for high morbidity and mortality rates in the western world. Several lines of evidence support a role for neutrophils in the development of atherosclerosis and its progression.

Neutrophil gelatinase-associated lipocalin (NGAL), also known as Lipocalin-2, is a 25-kDa secretory glycoprotein that was originally identified in mouse kidney cells and human neutrophil granules. This protein has been used as a marker of neutrophil activation in several studies, while recently it was found to be an inflammatory marker closely related to obesity and its metabolic complications.

Recently, lactoferrin, a protein which co-localizes with NGAL in the specific granules of human neutrophils has been proposed as a more dynamic marker of neutrophil activation compared to the widely used myeloperoxidase in patients with CAD.

In line with the accumulating evidence, this study is designed to investigate the relationship between serum NGAL concentration and the presence or the severity of coronary artery disease according to coronary angiography.

Conditions

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Coronary Artery Disease Atherosclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with angiographically confirmed significant CAD

No interventions assigned to this group

2

Patients without significant CAD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Consenting patients undergoing coronary angiography due to suspected CAD based on clinical history and results from non-invasive testing

Exclusion Criteria

* Abnormal renal function
* Any known active inflammatory disease
* Receiving medical therapy with antibiotics, corticosteroids, immunosuppressive agents
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiovascular Research Society, Greece

OTHER

Sponsor Role lead

Responsible Party

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Athens Euroclinic

Principal Investigators

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Demosthenes Katritsis, MD,PhD

Role: STUDY_CHAIR

Athens Euroclinic and Cardiovascular Research Society

Locations

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Athens Euroclinic

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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3.8.9.2008

Identifier Type: -

Identifier Source: org_study_id

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