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

NCT ID: NCT00693329

Last Updated: 2009-12-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-12-31

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.

Conditions

Cardiovascular Surgery With Coronary Angiography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott RDx Cardiometabolic

OTHER

Sponsor Role: lead

Responsible Party

Biosite

Principal Investigators

Peter McCullough, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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

Countries

United States

Other Identifiers

BSTE-0406

Identifier Type: -

Identifier Source: org_study_id