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
  Purpose

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
Coronary Artery Disease
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neutrophil Gelatinase-associated Disease: a Potential Biomarker of the Severity of Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Cardiovascular Research Society, Greece:

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 73
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with angiographically confirmed significant CAD
2
Patients without significant CAD

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted for coronary angiography.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749281

Locations
Greece
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
  More Information

No publications provided

Responsible Party: Department of Cardiology, Athens Euroclinic
ClinicalTrials.gov Identifier: NCT00749281     History of Changes
Other Study ID Numbers: 3.8.9.2008
Study First Received: September 8, 2008
Last Updated: July 7, 2010
Health Authority: Greece: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 22, 2014