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

This study has been completed.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00693329
First received: June 5, 2008
Last updated: December 17, 2009
Last verified: December 2009
  Purpose

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.


Condition
Cardiovascular Surgery With Coronary Angiography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neutrophil Gelatinase-associated Lipcalin(NGAL): A Novel Blood Marker for Determining the Risk of Developing Contrast-Induced Nephopathy

Further study details as provided by Biosite:

Biospecimen Retention:   Samples Without DNA

Blood sample taken at 8 timepoints over 2 days.


Estimated Enrollment: 260
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing intra-arterial angiography involving administration of iodinated contrast agent(s).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693329

Locations
United States, Michigan
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
Providence Hospital
Providence, Michigan, United States, 48075
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Biosite
Investigators
Principal Investigator: Peter McCullough, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kyle Fortner, CRA, Biosite
ClinicalTrials.gov Identifier: NCT00693329     History of Changes
Other Study ID Numbers: BSTE-0406
Study First Received: June 5, 2008
Last Updated: December 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Biosite:
Contrast Induced Nephrophathy (CIN)
Kidney
NGAL

ClinicalTrials.gov processed this record on October 23, 2014