Status:
COMPLETED
Iodixanol vs. Iomeprol to Prevent Contrast-Induced Nephropathy After Coronary Intervention (CONTRAST)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Renal Insufficiency, Chronic
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 i...
Detailed Description
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 contr...
Eligibility Criteria
Inclusion
- chronic renal failure
- Informed, written consent
Exclusion
- Cardiogenic shock
- Dialysis
- kidney transplantation
- Concurrent intake of nephrotoxic medication
- Planned or proceeded parenteral (i.v. or i.a.) administration of iodine-containing contrast medium at least 7 days before/after catheterization.
- Contra-indications for the use of Iodixanol (e.g. allergies)
- Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding
- Patient's inability to fully cooperate with the study protocol.
- Previous enrollment in this trial
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT00390585
Start Date
July 1 2006
End Date
December 1 2008
Last Update
March 15 2010
Active Locations (2)
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1
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
2
1. Medizinische Klinik, Klinikum rechts der Isar
München, Germany, 81675