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

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.
 
ClinicalTrials.gov Identifier: NCT00289029
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
Bracco Diagnostics, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
CIN Drug: Iopamidol 370 mgI/mL Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients
Study Start Date : July 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Iopamidol




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00289029


Locations
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United States, New Jersey
Bracco Diagnostics, Inc
Princeton, New Jersey, United States
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Director: Marie Morris Bracco Diagnostics, Inc
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ClinicalTrials.gov Identifier: NCT00289029    
Other Study ID Numbers: IOP104
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006