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

Deutsches Herzzentrum Muenchen324 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

324

Conditions

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

Interventions

Iodixanol 320DRUG

Iodixanol 320 is used as contrast media while coronary intervention.

Iomeprol 350DRUG

Iomeprol 350 is used as contrast media while coronary intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Deutsches Herzzentrum Muenchen

Munich, Germany

1. Medizinische Klinik, Klinikum rechts der Isar

München, Germany

Outcomes

Primary Outcomes

Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization

Time frame: primary hospitalization

Secondary Outcomes

Duration of primary hospitalization

Time frame: Duration of primary hospitalization

Incidence of severe acute kidney failure

Time frame: severe acute kidney failure

Contrast-induced nephropathy six months after PCI

Time frame: 6 months

Mortality and myocardial infarction at 6 and 12 months

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

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