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

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00390585
First received: October 19, 2006
Last updated: March 12, 2010
Last verified: February 2008
  Purpose

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).


Condition Intervention Phase
Renal Insufficiency, Chronic
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Arteriosclerosis
Drug: Iodixanol 320
Drug: Iomeprol 350
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization [ Time Frame: primary hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of primary hospitalization [ Time Frame: Duration of primary hospitalization ] [ Designated as safety issue: Yes ]
  • Incidence of severe acute kidney failure [ Time Frame: severe acute kidney failure ] [ Designated as safety issue: Yes ]
  • Contrast-induced nephropathy six months after PCI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Mortality and myocardial infarction at 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 324
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Iodixanol 320
Drug: Iodixanol 320
Iodixanol 320 is used as contrast media while coronary intervention.
Other Name: VISIPAQUE (TM)
Active Comparator: B
Iomeprol 350
Drug: Iomeprol 350
Iomeprol 350 is used as contrast media while coronary intervention.
Other Name: Imeron

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390585

Locations
Germany
1. Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany, 81675
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Albert Schoemig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Rainer Wessely, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:
Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00390585     History of Changes
Other Study ID Numbers: GE IDE No. E00605
Study First Received: October 19, 2006
Last Updated: March 12, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
Renal Insufficiency
Angioplasty, Transluminal, Percutaneous Coronary
Contrast media

Additional relevant MeSH terms:
Renal Insufficiency
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Contrast Media
Iodixanol
Iomeprol
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014