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

Completed · Phase 2

Conditions studied: Chronic Renal Insufficiency, Diabete Mellitus, Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT01252810

Run by

GE Healthcare

People needed

284

Starts

2010-11-01

Expected to finish

2012-12-01

Last updated by the study team

2018-08-29

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GE Healthcare — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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