Conditions: Chronic Renal Insufficiency Diabete Mellitus Congestive Heart Failure
Keywords: CATH Catheterization CI-AKI Contrast-induced acute kidney injury DM Diabetes mellitus eGFR Estimated glomerular filtration rate MDRD Modification of Diet in Renal Disease NYHA New York Heart Association PCI Percutaneous coronary intervention SCr Serum creatinine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 284
Healthy volunteers: no

Brief summary:
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: GE-145
Intervention descriptions: intervention 1: GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.

Protocol document: