Neutrophil Gelatinase Associated Liocalin in Predicting AKI in Coronary Artery Disease

August 31, 2017 updated by: Bassant Rashad, Assiut University

The Role of Serum Neutrophil Gelatinase Associated Lipocalin in Predicting Acute Kidney Injury in Patients With Coronary Artery Disease

The aim of this work is to assess the clinical significance of serum levels of neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in patients exposed to PCI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

ST-elevated myocardial infarction(STEMI) patients are at a particularly high risk of acute kidney injury (AKI) because of the complexity of hemodynamic disorders and adverse effects associated with the use of radiopaque diagnostic and treatment methods (Smirnov AV.et al.,2009) With wide application of percutaneous coronary intervention (PCI) technology in patients with coronary artery disease (CAD), contrast-induced acute kidney injury (CI-AKI) has become a serious complication and is the third leading cause of AKI in hospitalized patients.(Gleeson.et al. 2004)

To date,AKI diagnosis has been limited to observation of increasing levels of serum creatinine,decrease in urine output,and alterations in urinary chemistry (Bellomo.et al.2004;Mehta.et al. 2007) Nevertheless,serum creatinine levels do not increase significantly until renal function has decreased to 50% in addition,the level of serum creatinine may be affected by the patient's muscle mass,catabolic state,protein intake,weight,sex and tubular secretion of creatinine.Therefore,applying serum creatinine as a biomarker for diagnosing AKI may result in the loss of valuable time (Mishra.et al.2005;Sirota.et al.2011)

Neutrophil Gelatinase-associated lipocalin(NGAL) belongs to the lipocalin family and is produced predominantly by the liver and white blood cells(Hvidberg.et al.,2005).

A small polypeptide, neutrophil gelatinase-associated lipocalin (NGAL), is one of the most promising and best-studied AKI biomarkers (Mishra.et al.,2003; Devarajan.et al 2003) The expression of NGAL was predominantly in proliferating and regenerating tubular epithelial cells, which suggested a role in repair. (Mori.et al.2005) The majority of NGAL, secreted by injured renal tubule epithelial cells, is in a 25kDa monomeric form. In contrast, neutrophils have been claimed to release NGAL primarily as a 45kDa homodimer, i.e. two NGAL monomers linked by a disulfide bridge. It also exists as a 135-kDa heterodimer, covalently conjugated with gelatinase (Cai.et al.2010) NGAL is easily detected in blood and urine due to its small size and resistance to degradation. It can be measured non-invasively using routine laboratory analysers as well as some point of care devices. Furthermore, NGAL concentration in both urine and plasma rises rapidly in a dose-dependent manner that is proportional to the degree of acute kidney damage (Haase-Fielitz.et al.2009)

NGAL has previously been termed the 'troponin-like' biomarker to detect subclinical AKI even in the absence of diagnostic increases in SCr (Devarajan.,2010;Haase,et al.2011) Additionally, NGAL has been reported to be predictive 48 h prior to the actual time of injury; therefore, renal replacement therapy can be planned earlier(Cruz,et al.2010)

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all male and female patients with coronary artery disease who are recently exposed to PCI (20_70 years old )

Description

Inclusion Criteria:

  • patients exposed to percutaneous coronary intervention

Exclusion Criteria:

  • 1.Diabetes mellitus 2.Liver disease 3.Chronic Kidney Disease 4.Renal Replacement Therapy 5.Previous kidney transplant 6.Chronic infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients
NGAL and renal functions will be measured two hours after Percutaneous coronary intervention and two days later as a follow up
Diagnostic test: Neutrophil gelatinase-associated lipocalin (NAGL)
Serum level of Neutrophil gelatinase-associated lipocalin (NAGL) using the enzyme linked immunosorbent assay kits (ELISA)
Healthy Group
control group
Diagnostic test: Neutrophil gelatinase-associated lipocalin (NAGL)
Serum level of Neutrophil gelatinase-associated lipocalin (NAGL) using the enzyme linked immunosorbent assay kits (ELISA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rise of NGAL in AKI after PCI before rise of renal function
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 15, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

September 15, 2019

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (ACTUAL)

August 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGAL in AKI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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