<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03266367</url>
  </required_header>
  <id_info>
    <org_study_id>NGAL in AKI</org_study_id>
    <nct_id>NCT03266367</nct_id>
  </id_info>
  <brief_title>Neutrophil Gelatinase Associated Liocalin in Predicting AKI in Coronary Artery Disease</brief_title>
  <official_title>The Role of Serum Neutrophil Gelatinase Associated Lipocalin in Predicting Acute Kidney Injury in Patients With Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this work is to assess the clinical significance of serum levels of neutrophil&#xD;
      gelatinase-associated lipocalin (NGAL) to predict AKI in patients exposed to PCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ST-elevated myocardial infarction(STEMI) patients are at a particularly high risk of acute&#xD;
      kidney injury (AKI) because of the complexity of hemodynamic disorders and adverse effects&#xD;
      associated with the use of radiopaque diagnostic and treatment methods (Smirnov AV.et&#xD;
      al.,2009) With wide application of percutaneous coronary intervention (PCI) technology in&#xD;
      patients with coronary artery disease (CAD), contrast-induced acute kidney injury (CI-AKI)&#xD;
      has become a serious complication and is the third leading cause of AKI in hospitalized&#xD;
      patients.(Gleeson.et al. 2004)&#xD;
&#xD;
      To date,AKI diagnosis has been limited to observation of increasing levels of serum&#xD;
      creatinine,decrease in urine output,and alterations in urinary chemistry (Bellomo.et&#xD;
      al.2004;Mehta.et al. 2007) Nevertheless,serum creatinine levels do not increase significantly&#xD;
      until renal function has decreased to 50% in addition,the level of serum creatinine may be&#xD;
      affected by the patient's muscle mass,catabolic state,protein intake,weight,sex and tubular&#xD;
      secretion of creatinine.Therefore,applying serum creatinine as a biomarker for diagnosing AKI&#xD;
      may result in the loss of valuable time (Mishra.et al.2005;Sirota.et al.2011)&#xD;
&#xD;
      Neutrophil Gelatinase-associated lipocalin(NGAL) belongs to the lipocalin family and is&#xD;
      produced predominantly by the liver and white blood cells(Hvidberg.et al.,2005).&#xD;
&#xD;
      A small polypeptide, neutrophil gelatinase-associated lipocalin (NGAL), is one of the most&#xD;
      promising and best-studied AKI biomarkers (Mishra.et al.,2003; Devarajan.et al 2003) The&#xD;
      expression of NGAL was predominantly in proliferating and regenerating tubular epithelial&#xD;
      cells, which suggested a role in repair. (Mori.et al.2005) The majority of NGAL, secreted by&#xD;
      injured renal tubule epithelial cells, is in a 25kDa monomeric form. In contrast, neutrophils&#xD;
      have been claimed to release NGAL primarily as a 45kDa homodimer, i.e. two NGAL monomers&#xD;
      linked by a disulfide bridge. It also exists as a 135-kDa heterodimer, covalently conjugated&#xD;
      with gelatinase (Cai.et al.2010) NGAL is easily detected in blood and urine due to its small&#xD;
      size and resistance to degradation. It can be measured non-invasively using routine&#xD;
      laboratory analysers as well as some point of care devices. Furthermore, NGAL concentration&#xD;
      in both urine and plasma rises rapidly in a dose-dependent manner that is proportional to the&#xD;
      degree of acute kidney damage (Haase-Fielitz.et al.2009)&#xD;
&#xD;
      NGAL has previously been termed the 'troponin-like' biomarker to detect subclinical AKI even&#xD;
      in the absence of diagnostic increases in SCr (Devarajan.,2010;Haase,et al.2011)&#xD;
      Additionally, NGAL has been reported to be predictive 48 h prior to the actual time of&#xD;
      injury; therefore, renal replacement therapy can be planned earlier(Cruz,et al.2010)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2017</start_date>
  <completion_date type="Anticipated">September 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The rise of NGAL in AKI after PCI before rise of renal function</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <description>NGAL and renal functions will be measured two hours after Percutaneous coronary intervention and two days later as a follow up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Group</arm_group_label>
    <description>control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Neutrophil gelatinase-associated lipocalin (NAGL)</intervention_name>
    <description>Serum level of Neutrophil gelatinase-associated lipocalin (NAGL) using the enzyme linked immunosorbent assay kits (ELISA)</description>
    <arm_group_label>Healthy Group</arm_group_label>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all male and female patients with coronary artery disease who are recently exposed to PCI&#xD;
        (20_70 years old )&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients exposed to percutaneous coronary intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Diabetes mellitus 2.Liver disease 3.Chronic Kidney Disease 4.Renal Replacement&#xD;
             Therapy 5.Previous kidney transplant 6.Chronic infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Basant R Mohamed, Dr</last_name>
    <phone>01008669457</phone>
    <email>touch_my_heart12345@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zeinab A Abdelhamed</last_name>
    <phone>01003233267</phone>
    <email>zeinabdoctor@yahoo.com</email>
  </overall_contact_backup>
  <results_reference>
    <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.</citation>
    <PMID>15312219</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>17331245</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>15811456</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>15670845</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>14514731</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>14654349</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>15711640</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>20829422</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>19474273</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>21511111</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>19956925</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Bassant Rashad</investigator_full_name>
    <investigator_title>Resident Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03266367
org study id: NGAL in AKI
nct id: NCT03266367
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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)
observational model: Case-Control
time perspective: Prospective
measure: The rise of NGAL in AKI after PCI before rise of renal function
time frame: 2 days
arm group label: patients
description: NGAL and renal functions will be measured two hours after Percutaneous coronary intervention and two days later as a follow up
arm group label: Healthy Group
description: control group
intervention type: Diagnostic Test
intervention name: Neutrophil gelatinase-associated lipocalin (NAGL)
description: Serum level of Neutrophil gelatinase-associated lipocalin (NAGL) using the enzyme linked immunosorbent assay kits (ELISA)
arm group label: Healthy Group
arm group label: patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Basant R Mohamed, Dr
phone: 01008669457
email: touch_my_heart12345@yahoo.com
last name: Zeinab A Abdelhamed
phone: 01003233267
email: zeinabdoctor@yahoo.com
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: 15312219
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: 17331245
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: 15811456
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: 15670845
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: 14514731
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: 14654349
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: 15711640
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: 20829422
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: 19474273
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: 21511111
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.
PMID: 19956925
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Bassant Rashad
investigator title: Resident Doctor
mesh term: Acute Kidney Injury
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No