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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Renal Insufficiency, Chronic, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis

Intervention / Treatment
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* Drug: Iodixanol 320
* Drug: Iomeprol 350


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Iodixanol 320 | Drug: Iodixanol 320<br>* Iodixanol 320 is used as contrast media while coronary intervention.<br>* Other names: VISIPAQUE (TM);|
| Active Comparator: B<br>Iomeprol 350 | Drug: Iomeprol 350<br>* Iomeprol 350 is used as contrast media while coronary intervention.<br>* Other names: Imeron;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Insufficiency, Angioplasty, Transluminal, Percutaneous Coronary, Contrast media