Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography

GE Healthcare

Overview

The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Conditions

Coronary Artery Disease (CAD)Renal Impairment Diabetes Mellitus

Interventions

Iodixanol, Ioversol, IopromideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as 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 transplantation or with CrCl \< 20 mL/min will not be included.

Locations (2)

GE Healthcare

Princeton, New Jersey, United States

GE Healthcare

Munich, Germany

Outcomes

Primary Outcomes

Primary endpoint:

Maximum peak increase in SCr from baseline up to day 3.

Secondary endpoints:

Change in SCr from baseline to day 2 and to day 3

Number of subjects with contrast-induced nephropathy (CIN)

Quality of diagnostic information

Secondary Outcomes

Coronary Artery Disease (CAD)

Renal Impairment

Diabetes mellitus

Data from ClinicalTrials.gov

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