Iodixanol 320
DrugIodixanol 320 is used as contrast media while coronary intervention.
Other names: VISIPAQUE (TM)
NCT Number: NCT00390585
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Deutsches Herzzentrum Muenchen, Munich, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Iodixanol 320 is used as contrast media while coronary intervention.
Other names: VISIPAQUE (TM)
Iomeprol 350 is used as contrast media while coronary intervention.
Other names: Imeron
Time frame: primary hospitalization
Time frame: Duration of primary hospitalization
Time frame: severe acute kidney failure
Time frame: 6 months
Time frame: 6 and 12 months
Deutsches Herzzentrum Muenchen
Other
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
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