NCT Number: NCT00693329
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.
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Cardiac and Vascular Research Center of Northern Michigan, Petoskey, Michigan, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Sponsors and collaborators
Lead sponsor
Abbott RDx Cardiometabolic
Other
Registry information
Acronym: ENCINO
Important dates
- Study start
- 2008
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Jun 9, 2008
- Registry last updated
- Dec 18, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.