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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
  Purpose

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
Renal Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the "Renal Troponin" in Invasive Cardiology?

Further study details as provided by University of Freiburg:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

urinary samples


Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: February 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
consecutive, PCP patients
All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

all consecutive patients

Criteria

Inclusion Criteria:

  • All except patients with exclusion criteria

Exclusion Criteria:

  • dialysis-dependent chronic kidney disease
  • lack of written consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612117

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

No publications provided

Responsible Party: Geraldine Collaud, Ms, University of Freiburg
ClinicalTrials.gov Identifier: NCT01612117     History of Changes
Other Study ID Numbers: 013-REP-CER-FR
Study First Received: May 30, 2012
Last Updated: June 4, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Freiburg:
renal failure
cardiology
contrast-induced nephropathy

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013