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

Completed

• Conditions: Cardiovascular Surgery With Coronary Angiography

• Registration Number: NCT00693329
• Lead Sponsor: Abbott RDx Cardiometabolic

Brief 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Primary Completion: 2009-06
• Status Verified: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Cardiac and Vascular Research Center of Northern Michigan; 🇺🇸 Petoskey, Michigan, United States

Providence Hospital; 🇺🇸 Providence, Michigan, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States