NCT03266367

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 28, 2017

Last Update Submit

August 31, 2017

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • The rise of NGAL in AKI after PCI before rise of renal function

    2 days

Study Arms (2)

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)

Healthy Group

control group

Diagnostic Test: Neutrophil gelatinase-associated lipocalin (NAGL)

Interventions

Neutrophil gelatinase-associated lipocalin (NAGL)DIAGNOSTIC_TEST

Serum level of Neutrophil gelatinase-associated lipocalin (NAGL) using the enzyme linked immunosorbent assay kits (ELISA)

Healthy Grouppatients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • patients exposed to percutaneous coronary intervention

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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: 15312219RESULT

  • 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: 17331245RESULT

  • 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: 15811456RESULT

  • 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: 15670845RESULT

  • 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: 14514731RESULT

  • 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: 14654349RESULT

  • 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: 15711640RESULT

  • 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: 20829422RESULT

  • 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: 19474273RESULT

  • 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: 21511111RESULT

  • 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: 19956925RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Basant R Mohamed, Dr

CONTACT

01008669457touch_my_heart12345@yahoo.com

Zeinab A Abdelhamed

CONTACT

01003233267zeinabdoctor@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

September 15, 2017

Primary Completion

December 1, 2018

Study Completion

September 15, 2019

Last Updated

September 5, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share