Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT03266367
Status:
UNKNOWN
Last Update Posted:
2017-09-05
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neutrophil Gelatinase Associated Liocalin in Predicting AKI in Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rise of NGAL in AKI after PCI before rise of renal function', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '15312219', 'type': 'RESULT', 'citation': 'Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.'}, {'pmid': '17331245', 'type': 'RESULT', 'citation': 'Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.'}, {'pmid': '15811456', 'type': 'RESULT', 'citation': 'Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X.'}, {'pmid': '15670845', 'type': 'RESULT', 'citation': 'Hvidberg V, Jacobsen C, Strong RK, Cowland JB, Moestrup SK, Borregaard N. The endocytic receptor megalin binds the iron transporting neutrophil-gelatinase-associated lipocalin with high affinity and mediates its cellular uptake. FEBS Lett. 2005 Jan 31;579(3):773-7. doi: 10.1016/j.febslet.2004.12.031.'}, {'pmid': '14514731', 'type': 'RESULT', 'citation': 'Mishra J, Ma Q, Prada A, Mitsnefes M, Zahedi K, Yang J, Barasch J, Devarajan P. Identification of neutrophil gelatinase-associated lipocalin as a novel early urinary biomarker for ischemic renal injury. J Am Soc Nephrol. 2003 Oct;14(10):2534-43. doi: 10.1097/01.asn.0000088027.54400.c6.'}, {'pmid': '14654349', 'type': 'RESULT', 'citation': 'Devarajan P, Mishra J, Supavekin S, Patterson LT, Steven Potter S. Gene expression in early ischemic renal injury: clues towards pathogenesis, biomarker discovery, and novel therapeutics. Mol Genet Metab. 2003 Dec;80(4):365-76. doi: 10.1016/j.ymgme.2003.09.012.'}, {'pmid': '15711640', 'type': 'RESULT', 'citation': "Mori K, Lee HT, Rapoport D, Drexler IR, Foster K, Yang J, Schmidt-Ott KM, Chen X, Li JY, Weiss S, Mishra J, Cheema FH, Markowitz G, Suganami T, Sawai K, Mukoyama M, Kunis C, D'Agati V, Devarajan P, Barasch J. Endocytic delivery of lipocalin-siderophore-iron complex rescues the kidney from ischemia-reperfusion injury. J Clin Invest. 2005 Mar;115(3):610-21. doi: 10.1172/JCI23056."}, {'pmid': '20829422', 'type': 'RESULT', 'citation': 'Cai L, Rubin J, Han W, Venge P, Xu S. The origin of multiple molecular forms in urine of HNL/NGAL. Clin J Am Soc Nephrol. 2010 Dec;5(12):2229-35. doi: 10.2215/CJN.00980110. Epub 2010 Sep 9.'}, {'pmid': '19474273', 'type': 'RESULT', 'citation': 'Haase-Fielitz A, Bellomo R, Devarajan P, Bennett M, Story D, Matalanis G, Frei U, Dragun D, Haase M. The predictive performance of plasma neutrophil gelatinase-associated lipocalin (NGAL) increases with grade of acute kidney injury. Nephrol Dial Transplant. 2009 Nov;24(11):3349-54. doi: 10.1093/ndt/gfp234. Epub 2009 May 27.'}, {'pmid': '21511111', 'type': 'RESULT', 'citation': 'Haase M, Devarajan P, Haase-Fielitz A, Bellomo R, Cruz DN, Wagener G, Krawczeski CD, Koyner JL, Murray P, Zappitelli M, Goldstein SL, Makris K, Ronco C, Martensson J, Martling CR, Venge P, Siew E, Ware LB, Ikizler TA, Mertens PR. The outcome of neutrophil gelatinase-associated lipocalin-positive subclinical acute kidney injury: a multicenter pooled analysis of prospective studies. J Am Coll Cardiol. 2011 Apr 26;57(17):1752-61. doi: 10.1016/j.jacc.2010.11.051.'}, {'pmid': '19956925', 'type': 'RESULT', 'citation': 'Cruz DN, de Cal M, Garzotto F, Perazella MA, Lentini P, Corradi V, Piccinni P, Ronco C. Plasma neutrophil gelatinase-associated lipocalin is an early biomarker for acute kidney injury in an adult ICU population. Intensive Care Med. 2010 Mar;36(3):444-51. doi: 10.1007/s00134-009-1711-1. Epub 2009 Dec 3.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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)\n\nTo 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)\n\nNeutrophil Gelatinase-associated lipocalin(NGAL) belongs to the lipocalin family and is produced predominantly by the liver and white blood cells(Hvidberg.et al.,2005).\n\nA 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)\n\nNGAL 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)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all male and female patients with coronary artery disease who are recently exposed to PCI (20\\_70 years old )', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients exposed to percutaneous coronary intervention\n\nExclusion Criteria:\n\n* 1.Diabetes mellitus 2.Liver disease 3.Chronic Kidney Disease 4.Renal Replacement Therapy 5.Previous kidney transplant 6.Chronic infection'}, 'identificationModule': {'nctId': 'NCT03266367', 'briefTitle': 'Neutrophil Gelatinase Associated Liocalin in Predicting AKI in Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Role of Serum Neutrophil Gelatinase Associated Lipocalin in Predicting Acute Kidney Injury in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'NGAL in AKI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients', 'description': 'NGAL and renal functions will be measured two hours after Percutaneous coronary intervention and two days later as a follow up', 'interventionNames': ['Diagnostic Test: Neutrophil gelatinase-associated lipocalin (NAGL)']}, {'label': 'Healthy Group', 'description': 'control group', 'interventionNames': ['Diagnostic Test: Neutrophil gelatinase-associated lipocalin (NAGL)']}], 'interventions': [{'name': 'Neutrophil gelatinase-associated lipocalin (NAGL)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum level of Neutrophil gelatinase-associated lipocalin (NAGL) using the enzyme linked immunosorbent assay kits (ELISA)', 'armGroupLabels': ['Healthy Group', 'patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Basant R Mohamed, Dr', 'role': 'CONTACT', 'email': 'touch_my_heart12345@yahoo.com', 'phone': '01008669457'}, {'name': 'Zeinab A Abdelhamed', 'role': 'CONTACT', 'email': 'zeinabdoctor@yahoo.com', 'phone': '01003233267'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor', 'investigatorFullName': 'Bassant Rashad', 'investigatorAffiliation': 'Assiut University'}}}}