Iodixanol vs. Iomeprol to Prevent Contrast-Induced Nephropathy After Coronary Intervention (CONTRAST)

Last updated: March 12, 2010
Sponsor: Deutsches Herzzentrum Muenchen
Overall Status: Completed

Phase

4

Condition

Cardiac Disease

Myocardial Ischemia

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT00390585
GE IDE No. E00605
  • Ages > 18
  • All Genders

Study 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 in patients with impaired renal function undergoing percutaneous coronary interventions (PCI).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • chronic renal failure

  • Informed, written consent

Exclusion

Exclusion Criteria:

  • Cardiogenic shock

  • Dialysis

  • kidney transplantation

  • Concurrent intake of nephrotoxic medication

  • Planned or proceeded parenteral (i.v. or i.a.) administration of iodine-containingcontrast 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 testpositive for pregnancy, who have given birth within the last 90 days, who arebreastfeeding

  • Patient's inability to fully cooperate with the study protocol.

  • Previous enrollment in this trial

Study Design

Total Participants: 324
Study Start date:
July 01, 2006
Estimated Completion Date:
December 31, 2008

Study 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 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.

Connect with a study center

  • 1. Medizinische Klinik, Klinikum rechts der Isar

    Muenchen, 81675
    Germany

    Site Not Available

  • Deutsches Herzzentrum Muenchen

    Munich, 80636
    Germany

    Site Not Available

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