Neutrophil Gelatinase-associated Lipocalin Concentration in Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749281
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : July 8, 2010
Information provided by:
Cardiovascular Research Society, Greece

Brief Summary:
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.

Condition or disease
Coronary Artery Disease Atherosclerosis

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neutrophil Gelatinase-associated Disease: a Potential Biomarker of the Severity of Coronary Artery Disease
Study Start Date : September 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Patients with angiographically confirmed significant CAD
Patients without significant CAD

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted for coronary angiography.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749281

Athens Euroclinic
Athens, Attica, Greece, 11521
Sponsors and Collaborators
Cardiovascular Research Society, Greece
Study Chair: Demosthenes Katritsis, MD,PhD Athens Euroclinic and Cardiovascular Research Society

Responsible Party: Department of Cardiology, Athens Euroclinic Identifier: NCT00749281     History of Changes
Other Study ID Numbers:
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: July 8, 2010
Last Verified: August 2009

Keywords provided by Cardiovascular Research Society, Greece:
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases