Clinical trial NCT01252810: Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: i3 Statprobe
name: Medpace, Inc.
name: Biomedical Systems
name: Rules-Based Medicine, Inc.
First posted: 2010-12-03
Enrollment: 284
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
timeFrame: After the imaging date for either Ioforminol or Iopamidol.
Secondary outcomes:
measure: 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
timeFrame: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.
measure: Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections
timeFrame: 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Rubin Sheng, M.D.
role: STUDY_DIRECTOR
References: