Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
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 damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
Coronary Artery Disease
Drug: Iodixanol 320 mgI/mL
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
|Official Title:||GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.|
- Peak increase in SCr
- Incidence of contrast media-induced nephropathy from baseline up to day 3.
- SCr concentrations up to days 3 and 7
- image quality
- occurrence of adverse events and their severity and relationship with the contrast media.
|Study Start Date:||August 2005|
GEHC has decided not to provide this detail
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209430
|Amersham Health S.A|
|Study Director:||Caroline Widlund, BSc RN||GE Healthcare|
|Study Director:||Johnny Gibbs, Jr., B.S., CCRA||609-514-6809|