Status:
COMPLETED
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
Lead Sponsor:
GE Healthcare
Conditions:
Coronary Artery Disease
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney da...
Detailed Description
GEHC has decided not to provide this detail
Eligibility Criteria
Inclusion
- Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.
Exclusion
- Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00209430
Start Date
August 1 2005
Last Update
October 31 2007
Active Locations (1)
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1
Amersham Health S.A
Solna, Sweden