A Phase II Open-Labeled Study to Evaluate CardioPET™ as a PET Imaging Agent for Evaluation of Myocardial Perfusion and Fatty Acid Uptake in Subjects With Coronary Artery Disease

Fecha de inicio: 1 de marzo de 2013

Inclusion Criteria: Subjects must provide written informed consent prior to any study related procedures; Male and female subjects over 30 years of age with known or suspected CAD; Subjects have been evaluated as having known or suspected CAD by either exercise or pharmacologic MPI or echocardiography with ≥2 segments of ischemia and have been referred to coronary angiography for known or suspected CAD; Subjects must be able to complete all evaluations within 30 days of Tc-99m MPI imaging, and must be without any intervention or change in symptoms between the tests. Exclusion Criteria: Past or present use of medications that target fatty acid uptake or metabolism, e.g. Ranexa® (Ranolazine); Acute changes in comparison to most recent ECG; Suspected acute coronary syndrome; Chronic renal failure (Cr > 2.5); Anemia (Hgb < 10 within past 2 weeks); NYHA Class III or IV Congestive heart failure; Severe heart valve disease; Any exposure to any investigational drugs or devices, within 30 days prior to imaging study; Any acute or unstable physical or psychological disease judged by the Investigators based on medical history or screening physical examination; Female subjects only: Subject that has a positive pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing. Females not of child-bearing potential require confirmatory documentation in their medical records or must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days following CardioPET™ administration. Male subjects: Reliable contraception method from the first injection with the tracer until 3 months after the last injection with the tracer. The following contraceptive method(s) is (are) allowed during the study: Condom. If your partner becomes pregnant during the study, you should immediately report this to the investigator.