NCT00693329

Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 260 (estimated)
• Sponsor: Abbott RDx Cardiometabolic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiovascular Surgery With Coronary Angiography

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2008-06-09
• Last updated: 2009-12-18

Locations

3 sites across 1 country: United States