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Neutrophil Gelatinase-associated Lipocalin Concentration in Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by:
Cardiovascular Research Society, Greece
ClinicalTrials.gov Identifier:
NCT00749281
First received: September 8, 2008
Last updated: July 7, 2010
Last verified: August 2009
History of Changes

September 8, 2008
July 7, 2010
September 2008
March 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00749281 on ClinicalTrials.gov Archive Site
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Neutrophil Gelatinase-associated Lipocalin Concentration in Coronary Artery Disease
Neutrophil Gelatinase-associated Disease: a Potential Biomarker of the Severity of Coronary Artery Disease

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum
Non-Probability Sample

Patients admitted for coronary angiography.
  • Coronary Artery Disease
  • Atherosclerosis
Not Provided
  • 1
    Patients with angiographically confirmed significant CAD
  • 2
    Patients without significant CAD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
September 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00749281
3.8.9.2008
Yes
Department of Cardiology, Athens Euroclinic
Cardiovascular Research Society, Greece
Not Provided
Study Chair: Demosthenes Katritsis, MD,PhD Athens Euroclinic and Cardiovascular Research Society
Cardiovascular Research Society, Greece
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP