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

May 27, 2014 updated by: Stéphane Cook, Prof, University of Freiburg

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Fribourg
      • Freiburg, Fribourg, Switzerland, 1708
        • Department of cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all consecutive patients

Description

Inclusion Criteria:

  • All except patients with exclusion criteria

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-6 hours after PCP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-6 hours after PCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Freiburg

Investigators

  • Study Chair: Stephane Cook, MD, University Fribourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013-REP-CER-FR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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