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Kidney Damage in Patients With Normal eGFR

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01137786
First Posted: June 4, 2010
Last Update Posted: September 30, 2013
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):
Bracco Diagnostics, Inc
  Purpose
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 Intervention Phase
Coronary Artery Stenosis Drug: Non ionic contrast media comparator Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • 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.


Enrollment: 49
Study Start Date: December 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  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): NCT01137786


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

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01137786     History of Changes
Other Study ID Numbers: IOP-116
First Submitted: June 3, 2010
First Posted: June 4, 2010
Results First Submitted: May 22, 2013
Results First Posted: September 30, 2013
Last Update Posted: September 30, 2013
Last Verified: April 2012

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