Coronary Artery Disease, Renal Impairment
Conditions
Keywords
Iodixanol, Iopamidol, coronary angiography, Contrast media-induced nephropathy
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
Interventions
Sponsors
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak increase in SCr | — |
| Incidence of contrast media-induced nephropathy from baseline up to day 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| SCr concentrations up to days 3 and 7 | — |
| image quality | — |
| occurrence of adverse events and their severity and relationship with the contrast media. | — |
Countries
Sweden
Outcome results
None listed