Title
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure
Phase
Phase 2Lead Sponsor
General ElectricStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Renal Insufficiency Diabete Mellitus Congestive Heart FailureIntervention/Treatment
ioforminol ...Study Participants
284To 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.
GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
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.
| Event Type | Organ System | Event Term | Ioforminol 320mg I/ml Injection | Iopamidol 370mg I/ml Injection |
|---|
Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.
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.
Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).
