Kidney Damage In Patients With Severe Fall In eGFR

February 20, 2014 updated by: Bracco Diagnostics, Inc

A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Severe Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Institu De Cardiologie De Montreal

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provides written Informed Consent
  • Is at least 18 years of age;
  • Is scheduled for or likely to undergo percutaneous coronary intervention;
  • Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.

Exclusion Criteria:

  • Is a pregnant or lactating female
  • Has a history of severe congestive heart failure
  • Has a history of hyperthyroidism
  • Has unstable renal function
  • Has a history of hypersensitivity to iodinated contrast agents

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IOPAMIDOL injection 370
Drug: Iopamidol 370
one time administration for PCI
Other Names:
  • Isovue 370
Active Comparator: Iodixanol 320
Drug: Iodixanol 320
Iodixanol 320 single injection for percutaneous coronary injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.
Time Frame: Baseline and 2,4,6,24, 48, and 72 hours post-dose
Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.
Baseline and 2,4,6,24, 48, and 72 hours post-dose

Collaborators and Investigators

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

Sponsor

Bracco Diagnostics, Inc

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, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 4, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOP-118

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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