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

Phase 4

Completed

• Conditions: Renal Insufficiency, Chronic; Coronary Arteriosclerosis; Angioplasty, Transluminal, Percutaneous Coronary
• Interventions: Drug: Iodixanol 320; Drug: Iomeprol 350

• Registration Number: NCT00390585
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief 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).

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-10-19
• Study First Submitted QC: 2006-10-19
• Study First Posted: 2006-10-20
• Primary Completion: 2008-01
• Status Verified: 2008-02
• Study Completion: 2008-12
• Last Update Submitted: 2010-03-12
• Last Update Posted: 2010-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Iodixanol 320	Iodixanol 320
B	Iomeprol 350	Iomeprol 350

Primary Outcome Measures

Name	Time	Method
Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization	primary hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (2)

1. Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Muenchen, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany