Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome

Open-label, Phase 2 Study of the Safety and Efficacy of B-methyl-P-(123I)- Iodophenyl-pentadecanoic Acid (Iodofiltic Acid I 123) For Identification of Ischemic Myocardium Using Single Photon Emission Computed Tomography (Spect) in Adults With Symptoms Consistent With Acute Coronary Syndrome (ACS).

This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. The resulting independent reading of the images will be compared against the truth standard for ACS.

Inclusion Criteria:

• Provide written informed consent and are willing to comply with protocol requirements
• Are 40 years of age or older.
• Are being evaluated for possible ACS.
• If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.

Exclusion Criteria:

• <40 years of age.
• Females who are pregnant or lactating.
• History of left ventricular ejection fraction (LVEF)=40%.
• History of MI.
• Acute ST segment elevation on ECG.
• Left bundle branch block on ECG.
• Known history of significant allergy to x-ray contrast media or iodine/iodides.
• Currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (Ranexa).
• Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment.
• Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.
• Serum creatinine level >2.0 mg per dL.
• Received investigational compound and/or medical device within 30 days of admission into this study.
• Q-wave abnormalities consistent with previous MI