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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Geraldine Collaud, University of Freiburg
ClinicalTrials.gov Identifier:
NCT01612117
First received: May 30, 2012
Last updated: June 4, 2012
Last verified: May 2012
History of Changes

May 30, 2012
June 4, 2012
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 ] [ Designated as safety issue: No ]
cf title
Same as current
Complete list of historical versions of study NCT01612117 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
cf. title
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

urinary samples
Probability Sample

all consecutive patients
Renal Failure
Not Provided
consecutive, PCP patients
All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
February 2013
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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01612117
013-REP-CER-FR
No
Geraldine Collaud, University of Freiburg
University of Freiburg
Not Provided
Study Chair: Stephane Cook, MD University Fribourg
University of Freiburg
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP