Neutrophil Gelatinase-associated Lipocalin Concentration in Coronary Artery Disease

Sponsor

Cardiovascular Research Society, Greece (Other)

Overall Status

Completed

CT.gov ID

NCT00749281

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

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 :

Sep 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
1 Patients with angiographically confirmed significant CAD
2 Patients without significant CAD

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Athens Euroclinic	Athens	Attica	Greece	11521

Sponsors and Collaborators

Cardiovascular Research Society, Greece

Investigators

Study Chair: Demosthenes Katritsis, MD,PhD, Athens Euroclinic and Cardiovascular Research Society

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00749281

Other Study ID Numbers:

3.8.9.2008

First Posted:

Sep 9, 2008

Last Update Posted:

Jul 8, 2010

Last Verified:

Aug 1, 2009

Keywords provided by , ,

atherosclerosis

ngal

coronary artery disease

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Atherosclerosis

Study Results

No Results Posted as of Jul 8, 2010