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

Overview

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).

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2008

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 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.

Interventions

  • Drug: Iodixanol 320
    • Iodixanol 320 is used as contrast media while coronary intervention.
  • Drug: Iomeprol 350
    • Iomeprol 350 is used as contrast media while coronary intervention.

Arms, Groups and Cohorts

  • Experimental: A
    • Iodixanol 320
  • Active Comparator: B
    • Iomeprol 350

Clinical Trial Outcome Measures

Primary Measures

  • Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization
    • Time Frame: primary hospitalization

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • chronic renal failure – Informed, written consent Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Deutsches Herzzentrum Muenchen
  • Provider of Information About this Clinical Study
    • Prof. A. Schömig, Deutsches Herzzentrum Munich
  • Overall Official(s)
    • Albert Schoemig, MD, Study Chair, Deutsches Herzzentrum Muenchen
    • Rainer Wessely, MD, Principal Investigator, Deutsches Herzzentrum Muenchen

References

Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.

Citations Reporting on Results

Wessely R, Koppara T, Bradaric C, Vorpahl M, Braun S, Schulz S, Mehilli J, Schomig A, Kastrati A; Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty Trial Investigators. Choice of contrast medium in patients with impaired renal function undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2009 Oct;2(5):430-7. doi: 10.1161/CIRCINTERVENTIONS.109.874933. Epub 2009 Sep 22.

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