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A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac Angiography

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00289029
First received: February 7, 2006
Last updated: August 17, 2006
Last verified: August 2006
History of Changes
  Purpose

The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with moderate to severe renal insufficiency undergoing cardiac angiography. Serum creatinine will be measured before and up to 48-72 hours after the administration of the contrast agent to evaluate renal function.


Condition Intervention Phase
CIN
 Drug: Iopamidol 370 mgI/mL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients

Resource links provided by NLM:

Drug Information available for: Iopamidol
U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Increase in SCr at 48-72 hours post dose

Secondary Outcome Measures:
  • Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate

Estimated Enrollment: 400
Study Start Date: July 2005
Estimated Study Completion Date: June 2006
  Eligibility

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

Inclusion Criteria:

  • Referred for cardiac angiography; with a documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2

Exclusion Criteria:

  • Unstable renal function; concurrent administration of nephrotoxic drugs, undergoing dialysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289029

Locations
United States, New Jersey
Bracco Diagnostics, Inc
Princeton, New Jersey, United States
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Marie Morris Bracco Diagnostics, Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00289029     History of Changes
Other Study ID Numbers: IOP104
Study First Received: February 7, 2006
Last Updated: August 17, 2006
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013