Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01612117
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
Stéphane Cook, Prof, University of Freiburg

Brief Summary:

Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration.

This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.

Condition or disease
Renal Failure

Detailed Description:
Methods. We will enroll all consecutive patients undergoing PCP with iomeprolum during a 3-month period at our institution. CIN will be defined as a ≥25% increase in SCr from baseline when measured 2-4 days after PCP. uNGAL will be measured at its peak with the Abbott ARCHITECT assay.

Study Type : Observational
Actual Enrollment : 244 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the "Renal Troponin" in Invasive Cardiology?
Study Start Date : November 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

consecutive, PCP patients
All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention

Primary Outcome Measures :
  1. to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN [ Time Frame: 4-6 hours after PCP ]
    cf title

Secondary Outcome Measures :
  1. to study the relationship between the volume of contrast medium used for PCP and the uNGAL levels measured 4 to 6 hours thereafter [ Time Frame: 4-6 hours after PCP ]
    cf. title

Biospecimen Retention:   Samples Without DNA
urinary samples

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all consecutive patients

Inclusion Criteria:

  • All except patients with exclusion criteria

Exclusion Criteria:

  • dialysis-dependent chronic kidney disease
  • lack of written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01612117

Department of Cardiology
Freiburg, Fribourg, Switzerland, 1708
Sponsors and Collaborators
University of Freiburg
Study Chair: Stephane Cook, MD University Fribourg

Publications of Results:
Responsible Party: Stéphane Cook, Prof, Ms, University of Freiburg Identifier: NCT01612117     History of Changes
Other Study ID Numbers: 013-REP-CER-FR
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Stéphane Cook, Prof, University of Freiburg:
renal failure
contrast-induced nephropathy

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases