Coronary Artery Disease (CAD), Diabetes Mellitus, Renal Impairment
Conditions
Keywords
Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)
Brief summary
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.
Interventions
DRUGIodixanol, Ioversol, Iopromide
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of diagnostic information | — |
| Secondary endpoints: | — |
| Change in SCr from baseline to day 2 and to day 3 | — |
| Number of subjects with contrast-induced nephropathy (CIN) | — |
| Primary endpoint: | — |
| Maximum peak increase in SCr from baseline up to day 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal Impairment | — |
| Diabetes mellitus | — |
| Coronary Artery Disease (CAD) | — |
Countries
Germany, United States
Outcome results
None listed