Kidney Damage in Patients With Moderate Fall in eGFR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01136876
First received: June 2, 2010
Last updated: November 11, 2013
Last verified: September 2013
  Purpose

This is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59 mL/min. Statistical summaries will be presented to analyze the various lab tests results for the two groups.


Condition Intervention Phase
Coronary Artery Stenosis
Drug: Iopamidol
Drug: Iodixanol-320
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Moderate Fall in 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 in Comparison to a Non-ionic, Iso-osmolar Contrast Media [ Time Frame: Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 57
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-ionic iodinated contrast agent Drug: Iopamidol
Iopamidol 370, one time administration for percutaneous coronary intervention
Other Name: Isovue-370
Active Comparator: Non-ionic contrast media comparator Drug: Iodixanol-320
Iodixanol-320 single administration for percutaneous coronary intervention procedure
Other Name: Visipaque 320

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age and provides informed consent
  • Scheduled to undergo percutaneous coronary intervention
  • Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared

Exclusion Criteria:

  • Pregnant or lactating females
  • Severe congestive heart failure
  • History of hyperthyroidism;
  • Unstable renal function
  • Emergency PCI
  • History of hypersensitivity to iodinated contrast agents
  • Receiving diuretics to prevent acute renal injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136876

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

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01136876     History of Changes
Other Study ID Numbers: IOP-117
Study First Received: June 2, 2010
Results First Received: September 17, 2013
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014