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Neutrophil Gelatinase Associated Liocalin in Predicting AKI in Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT03266367
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Bassant Rashad, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Kidney Injury Diagnostic Test: Neutrophil gelatinase-associated lipocalin (NAGL)

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)


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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of Serum Neutrophil Gelatinase Associated Lipocalin in Predicting Acute Kidney Injury in Patients With Coronary Artery Disease
Estimated Study Start Date : September 15, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. The rise of NGAL in AKI after PCI before rise of renal function [ Time Frame: 2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 )
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03266367


Contacts
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Contact: Basant R Mohamed, Dr 01008669457 touch_my_heart12345@yahoo.com
Contact: Zeinab A Abdelhamed 01003233267 zeinabdoctor@yahoo.com

Sponsors and Collaborators
Assiut University

Publications of Results:

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Responsible Party: Bassant Rashad, Resident Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03266367     History of Changes
Other Study ID Numbers: NGAL in AKI
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases