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

GE Healthcare284 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

284

Conditions

Chronic Renal Insufficiency Diabete Mellitus Congestive Heart Failure

Interventions

GE-145DRUG

GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.

Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.

Time frame: After the imaging date for either Ioforminol or Iopamidol.

Secondary Outcomes

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

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.

Time frame: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.

Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections

Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).

Time frame: 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration

Data from ClinicalTrials.gov

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