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Completed

NCT Number: NCT00390585

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodixanol 320

Drug

Iodixanol 320 is used as contrast media while coronary intervention.

Other names: VISIPAQUE (TM)

Iomeprol 350

Drug

Iomeprol 350 is used as contrast media while coronary intervention.

Other names: Imeron

Primary outcomes

  1. Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization

    Time frame: primary hospitalization

Secondary outcomes

  1. Duration of primary hospitalization

    Time frame: Duration of primary hospitalization

  2. Incidence of severe acute kidney failure

    Time frame: severe acute kidney failure

  3. Contrast-induced nephropathy six months after PCI

    Time frame: 6 months

  4. Mortality and myocardial infarction at 6 and 12 months

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 20, 2006
Registry last updated
Mar 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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