Renal Insufficiency, Chronic Clinical Trial
Official title:
Prospective, Randomized, Comparative Study to Evaluate the Effect of Iodixanol 320 Compared to Iomeprol 350 on Contrast Medium Induced Nephropathy in Patients With Impaired Renal Function Undergoing PCI
The purpose of this study is to demonstrate that Iodixanol 320 is associated with a lower incidence of contrast-induced nephropathy (CIN) when compared with hyperosmolar contrast medium Iomeprol 350 in patients with impaired renal function undergoing percutaneous coronary interventions (PCI).
Iodixanol, an iso-osmolar, dimeric, non-ionic contrast agent has been shown to reduce the
risk of developing CIN in patients with elevated serum creatinine concentrations compared to
low-osmolar contrast agents. However, no information is available about a potential
protective effect of Iodixanol in patients with impaired renal function on CIN when used
during PCI. Due to the high volume of contrast exposition, patients with impaired renal
function are at increased risk for the development of CIN compared to patients with normal
excretory renal function.
The purpose of the investigation is to determine the changes of renal function in patients
with impaired renal function receiving Iodixanol 320 or Iomeprol 350 for percutaneous
coronary intervention.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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