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

March 12, 2010 updated by: Deutsches Herzzentrum Muenchen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenchen, Germany, 81675
        • 1. Medizinische Klinik, Klinikum rechts der Isar
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Iodixanol 320
Drug: Iodixanol 320
Iodixanol 320 is used as contrast media while coronary intervention.
Other Names:
  • VISIPAQUE (TM)
Active Comparator: B
Iomeprol 350
Drug: Iomeprol 350
Iomeprol 350 is used as contrast media while coronary intervention.
Other Names:
  • Imeron

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of primary hospitalization
Time Frame: Duration of primary hospitalization
Duration of primary hospitalization
Incidence of severe acute kidney failure
Time Frame: severe acute kidney failure
severe acute kidney failure
Contrast-induced nephropathy six months after PCI
Time Frame: 6 months
6 months
Mortality and myocardial infarction at 6 and 12 months
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Principal Investigator: Rainer Wessely, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 15, 2010

Last Update Submitted That Met QC Criteria

March 12, 2010

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. E00605

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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