An open, 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 percutaneous coronary intervention - CONTRAST

• Conditions: Patients with symptomatic coronary artery disease, impaired renal function (GFR<60ml/min) undergoing percutaneous coronary intervention

• Registration Number: EUCTR2005-003832-24-DE
• Lead Sponsor: Deutsches Herzzentrum München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-18
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

-Patients with a clinical indication for performing a diagnostic and/or interventional heart catheterization including a coronary angiography.
-Presence of chronic renal failure as defined by impaired glomerular filtration rate (GFR;<60ml/min) as assessed by the MDRD formula
-Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Age <18 years
-Cardiogenic shock
-Dialysis
-Prior kidney transplantation
-Concurrent intake of nephrotoxic medication (e.g., non-steroidal antiphlogistics, aminoglycosides)
-Contra-indications for the use of iodixanol and iomeprol
-Parenteral (i.v. or i.a.) administration of iodine-containing contrast medium either 7 days before or after the catheter intervention
-Presumed or demonstrated pregnancy
-Patient's inability to fully cooperate with the study protocol
-Prior participation to this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study will compare the incidence of contrast medium induced nephropathy (CIN) after a percutaneous coronary intervention in patients with impaired renal function receiving either the conventional hyperosmolar contrast medium Iomeprol 350 or the isoosmolar contast medium Iodixanol 320.;Secondary Objective: -Reassessment of primary end point at 6 months after the percutaneous coronary intervention<br>-Cardiovascular events within 12 months (death, myocardial infarction)<br>-Mortality within 12 months<br>-Duration of hospitalization<br>-Incidence of severe acute kidney failure ;Primary end point(s): The primary endpoint is CIN during primary hospitalization for coronary angioplasty. CIN is defined an increase of serum-creatinine following exposure to contrast medium. This definition adheres to commonly accepted criteria.