Status:
COMPLETED
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
i3 Statprobe
Medpace, Inc.
Conditions:
Chronic Renal Insufficiency
Diabete Mellitus
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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 insuffici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT01252810
Start Date
November 1 2010
End Date
December 1 2012
Last Update
August 29 2018
Active Locations (1)
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1
GE Healthcare
Princeton, New Jersey, United States, 08540