Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography

Phase 4CompletedNCT00209430

GE Healthcare408 enrolled

Overview

The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

GEHC has decided not to provide this detail

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

408

Conditions

Coronary Artery Disease Renal Impairment

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI. Exclusion Criteria: * Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.

Outcomes

Primary Outcomes

Peak increase in SCr

Incidence of contrast media-induced nephropathy from baseline up to day 3.

Secondary Outcomes

SCr concentrations up to days 3 and 7

image quality

occurrence of adverse events and their severity and relationship with the contrast media.