NCT00289029
Completed
Phase 4
Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients
ConditionsCIN
DrugsIopamidol 370 mgI/mL
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- CIN
- Sponsor
- Bracco Diagnostics, Inc
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Increase in SCr at 48-72 hours post dose
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Increase in SCr at 48-72 hours post dose
Secondary Outcomes
- Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate
Study Sites (1)
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