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Clinical Trials

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 Cathertization Procedure

Description

Status: Open to Enrollment

Start Date: Mar 04 2011

End Date: OPEN

This study is for people who are 70 years of age or older and have either impaired kidney function, diabetes which requires taking either insulin or other diabetes drug therapy; or those who have congestive heart failure and their doctor has referred them for a test called coronary angiography, sometimes called a cardiac (heart) CATH.  Coronary angiography is an X-ray examination of the blood vessels of the heart. A very small tube (catheter) is inserted into a blood vessel (artery) usually in your groin, and a special fluid (called a contrast media or dye) is injected. Contrast media is used because it is visible by X-ray, and as a result will produce clear pictures of the heart and the major blood vessels of the heart.  This CATH procedure is part of the patient’s routine care and has been ordered by their doctor prior to considering this study.

Purpose:

The purpose of this study is to compare the effects of an experimental contrast media called GE-145, to a known contrast media called Iopamidol (Isovue), on heart and kidney safety in older patients undergoing a CATH.  GE-145 is experimental which means that the Food and Drug Administration (FDA) has not yet approved it.  Isovue is an FDA approved contrast imaging media. Both GE-145 and Isovue contain iodine.

GE-145 and Isovue will be compared for overall safety, and overall picture quality. 

This is a Phase 2 study which means it will be done on a larger number of human subjects to see if a new drug is safe. It is also done to find out if the drug works and does what it is supposed to do.  This study will take place at approximately 30 hospitals in North America.  Approximately 250 subjects will be entered into this study over a period of 10 to 12 months.

Participant Eligibility:

[NOTE TO PATIENTS:  You may want to copy the following information and present it to your Doctor to determine your eligibility to participate in this study.]

Inclusion Criteria:

1. Males and females ≥70 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI and are expected to receive a total of between 80 mL and 200 mL of ICM administered during the procedure.
2. The subject has at least one of the following comorbidities:
   - Chronic renal insufficiency, (estimated glomerular filtration rate [eGFR] <60 but ≥15 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease [MDRD] equation) as measured within 2 weeks (if historic) or at the screening visit;
   - DM diagnosed >6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
   - CHF (New York Heart Association class III or greater) at the time of the screening visit.
3. The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.

Exclusion Criteria:      

1. The subject has known allergies to either iodine or any ICM.
2. The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
3. The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule.
4. The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
5. The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency.
6. The subject is not willing or unable to discontinue metformin (e.g., Glucophage®) at the time of the study procedure.
   Note: Metformin must not be taken at least 24 hours prior to the study procedures, withheld for at least 48 hours post-procedure, and restarted only after the subjects renal function has been evaluated and it is deemed safe to resume metformin.
7. The subject either received another investigational medicinal product (IMP) within 30 days of screening or will receive another IMP within the 7 day follow-up period.
8. The subject received another administration of ICM within 3 days prior to baseline or is scheduled to receive one within the 7 day follow-up period.
9. The subject has been previously enrolled in this study.
10. The subject presents any clinically active, serious, life-threatening disease, and/or has a life expectancy of less than 3 months or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.

Location of the Clinical Trial:

The University of Utah

How long will the study last:

Approximately 10 to 12 months

Principal Investigators

Rodney Badger, MD