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Kidney Damage in Patients With Normal 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: NCT01137786
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : September 30, 2013
Last Update Posted : September 30, 2013
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Brief Summary:
This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. 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: Non ionic contrast media comparator Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 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 Normal eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
Study Start Date : December 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: IOPAMIDOL 370 Drug: Non ionic contrast media comparator
One time administration for PCI
Other Name: Isovue 370

Active Comparator: IODIXANOL 320 Drug: Non ionic contrast media comparator
one time administration for PCI
Other Name: Visipaque 320

Primary Outcome Measures :
  1. Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low 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 non-ionic low osmolar contrast media.

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.

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

Inclusion Criteria:

  • Provides written Informed Consent and is willing to comply with protocol requirements;
  • Is at least 18 years of age;
  • Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
  • Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.

Exclusion Criteria:

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

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): NCT01137786

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United States, Illinois
Prairie Cardiovascular Consultants, Ltd.
Springfield, Illinois, United States, 62701
Sponsors and Collaborators
Bracco Diagnostics, Inc
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Study Director: Maria Luigia Storto, MD Bracco Diagnostics, Inc

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Responsible Party: Bracco Diagnostics, Inc Identifier: NCT01137786    
Other Study ID Numbers: IOP-116
First Posted: June 4, 2010    Key Record Dates
Results First Posted: September 30, 2013
Last Update Posted: September 30, 2013
Last Verified: April 2012
Additional relevant MeSH terms:
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Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases