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

General Electric (GE)

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Renal Impairment

Treatments

Drug: Iodixanol 320 mgI/mL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00209430

DXV405

Details and patient eligibility

About

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.

Full description

GEHC has decided not to provide this detail

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.