Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure

Inclusion Criteria:

• Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
• The subject has at least one of the following comorbidities:
• 1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
• 2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
• 3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.

Exclusion Criteria:

• The subject has known allergies to either iodine or any ICM.
• The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
• The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
• The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.