We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612117
First Posted: June 5, 2012
Last Update Posted: May 28, 2014
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.
Information provided by (Responsible Party):
Stéphane Cook, Prof, University of Freiburg
  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 Stéphane Cook, Prof, 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 ]
    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 ]
    cf. title


Biospecimen Retention:   Samples Without DNA
urinary samples

Enrollment: 244
Study Start Date: November 2011
Study Completion Date: February 2012
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

Inclusion Criteria:

  • All except patients with exclusion criteria

Exclusion Criteria:

  • dialysis-dependent chronic kidney disease
  • lack of written consent
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Stéphane Cook, Prof, Ms, University of Freiburg
ClinicalTrials.gov Identifier: NCT01612117     History of Changes
Other Study ID Numbers: 013-REP-CER-FR
First Submitted: May 30, 2012
First Posted: June 5, 2012
Last Update Posted: May 28, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases