Kidney Damage In Patients With Severe Fall In eGFR

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. Identifier: NCT01136915
Recruitment Status : Terminated (slow enrollment)
First Posted : June 4, 2010
Results First Posted : January 14, 2014
Last Update Posted : March 17, 2014
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Stenosis Drug: Iopamidol 370 Drug: Iodixanol 320 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : November 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: IOPAMIDOL injection 370 Drug: Iopamidol 370
one time administration for PCI
Other Name: Isovue 370
Active Comparator: Iodixanol 320 Drug: Iodixanol 320
Iodixanol 320 single injection for percutaneous coronary injection

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01136915

Canada, Quebec
Institu De Cardiologie De Montreal
Montreal, Quebec, Canada
Sponsors and Collaborators
Bracco Diagnostics, Inc

Responsible Party: Bracco Diagnostics, Inc Identifier: NCT01136915     History of Changes
Other Study ID Numbers: IOP-118
First Posted: June 4, 2010    Key Record Dates
Results First Posted: January 14, 2014
Last Update Posted: March 17, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases