Status:
COMPLETED
Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy
Lead Sponsor:
Abbott RDx Cardiometabolic
Conditions:
Cardiovascular Surgery With Coronary Angiography
Eligibility:
All Genders
18+ years
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...
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 pla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00693329
Start Date
March 1 2008
End Date
December 1 2009
Last Update
December 18 2009
Active Locations (3)
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1
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
2
Providence Hospital
Providence, Michigan, United States, 48075
3
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073