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

May 30, 2012
June 5, 2012
May 28, 2014
November 2011
February 2012   (Final data collection date for primary outcome measure)
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 ]
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Same as current
Complete list of historical versions of study NCT01612117 on Archive Site
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 ]
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Same as current
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Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology
Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the "Renal Troponin" in Invasive Cardiology?

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.

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.
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
urinary samples
Probability Sample
all consecutive patients
Renal Failure
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consecutive, PCP patients
All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention
Perrin T, Descombes E, Magnin JL, Gachet M, Hemett OM, Hayoz D, Stolt V, Baeriswyl G, Stauffer JC, Goy JJ, Togni M, Cook S. Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) and contrast-induced acute kidney injury after coronary angiogram. Swiss Med Wkly. 2013 Aug 27;143:w13853. doi: 10.4414/smw.2013.13853.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All except patients with exclusion criteria

Exclusion Criteria:

  • dialysis-dependent chronic kidney disease
  • lack of written consent
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Stéphane Cook, Prof, University of Freiburg
University of Freiburg
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Study Chair: Stephane Cook, MD University Fribourg
University of Freiburg
May 2014