Iodixanol vs. Iomeprol to Prevent Contrast-Induced Nephropathy After Coronary Intervention (CONTRAST)
|Renal Insufficiency, Chronic Angioplasty, Transluminal, Percutaneous Coronary Coronary Arteriosclerosis||Drug: Iodixanol 320 Drug: Iomeprol 350||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization [ Time Frame: primary hospitalization ]
- Duration of primary hospitalization [ Time Frame: Duration of primary hospitalization ]
- Incidence of severe acute kidney failure [ Time Frame: severe acute kidney failure ]
- Contrast-induced nephropathy six months after PCI [ Time Frame: 6 months ]
- Mortality and myocardial infarction at 6 and 12 months [ Time Frame: 6 and 12 months ]
|Study Start Date:||July 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Drug: Iodixanol 320
Iodixanol 320 is used as contrast media while coronary intervention.
Other Name: VISIPAQUE (TM)
Active Comparator: B
Drug: Iomeprol 350
Iomeprol 350 is used as contrast media while coronary intervention.
Other Name: Imeron
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390585
|1. Medizinische Klinik, Klinikum rechts der Isar|
|Muenchen, Germany, 81675|
|Deutsches Herzzentrum Muenchen|
|Munich, Germany, 80636|
|Study Chair:||Albert Schoemig, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Rainer Wessely, MD||Deutsches Herzzentrum Muenchen|