Iodixanol vs. Iomeprol to Prevent Contrast-Induced Nephropathy After Coronary Intervention (CONTRAST)
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|ClinicalTrials.gov Identifier: NCT00390585|
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : March 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency, Chronic Angioplasty, Transluminal, Percutaneous Coronary Coronary Arteriosclerosis||Drug: Iodixanol 320 Drug: Iomeprol 350||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||324 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||December 2008|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|