Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
Phase 4
Completed
- Conditions
- Coronary Artery DiseaseRenal Impairment
- Registration Number
- NCT00209430
- Lead Sponsor
- GE Healthcare
- Brief Summary
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.
- Detailed Description
GEHC has decided not to provide this detail
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 408
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Peak increase in SCr Incidence of contrast media-induced nephropathy from baseline up to day 3.
- Secondary Outcome Measures
Name Time Method SCr concentrations up to days 3 and 7 image quality occurrence of adverse events and their severity and relationship with the contrast media.
Trial Locations
- Locations (1)
Amersham Health S.A
🇸🇪Solna, Sweden