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

Phase 2

Completed

Conditions: Chronic Renal Insufficiency
Diabete Mellitus
Congestive Heart Failure

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.

Recruitment & Eligibility

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;
1. DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
1. 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.

Arm && Interventions

Group	Intervention	Description
GE 145 320mg I/ml injection	GE-145	-
Iopamidol 370mg I/ml injection	GE-145	-

Primary Outcome Measures

Name	Time	Method
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.	After the imaging date for either Ioforminol or Iopamidol.	Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.

Secondary Outcome Measures

Name	Time	Method
To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration	Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.	To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol. To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol. Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections	2, 6 and 24 hours post Ioforminol and Iopamidol adminstration	Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).