Clinical trial NCT00693329: Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy
Official title: Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Surgery With Coronary Angiography
Keywords: Contrast Induced Nephrophathy (CIN)
Kidney
NGAL
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2008-06-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing intra-arterial angiography involving administration of iodinated contrast agent(s).

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petoskey
country: United States
facility: Cardiac and Vascular Research Center of Northern Michigan
state: Michigan
city: Providence
country: United States
facility: Providence Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Peter McCullough, MD
role: PRINCIPAL_INVESTIGATOR
References: