Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy
Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy
This is a multi-center clinical study designed to assess the performance of the Triage NGAL
 test as an aid in the early risk assessment for contrast-induced nephropathy (CIN).
 Approximately 260 adults at risk for CIN undergoing intra-arterial angiography involving
 administration of iodinated contrast agent(s) will be enrolled.
EDTA anti-coagulated blood samples will be drawn at eight different time points from within 1
 hour prior to first contrast administration through 48 hours. These blood samples will be
 processed to plasma at the clinical site, frozen and shipped to Biosite for storage and
 testing of Triage NGAL and serum creatinine. The results of these assessments will be blinded
 to the medical team during the study and will not impact the medical management of the
 subject.

 Any additional serum creatinine measurements obtained by the medical team as part of routine
 care as well as need for dialysis, hospitalization, major adverse cardiovascular events and
 mortality will be recorded through Day 30.
Inclusion Criteria:

 -  Males and females 18 years of age or older;

 -  Undergoing angiographic procedure involving the intra-arterial administration of
 iodinated contrast agent(s);

 -  Chronic kidney disease indiacated by an eGFR < 75 ml/min/1.73 m2 based on screening
 labs performed ≤ 3 months prior to procedure.

 -  Able and willing to provide written informed consent for study participation and to
 comply with all study procedures.

 Exclusion Criteria:

 -  Renal transplant recipients

 -  Pre-existing evidence of acute renal failure at the time of enrollment.

 -  Already receiving dialysis (either acute or chronic) or in imminent need of dialysis
 at enrollment.

 -  Coronary artery bypass surgery or PCI within the previous 30 days.

 -  Participation in an interventional clinical study with an experimental therapy within
 the previous 30 days.

 -  Administration of intravasular contrast within the previous 30 days.

 -  Undergoing renal artery stenting.