BFPET for Regional Myocardial Perfusion Imaging

Inclusion Criteria:

- Subjects must provide written informed consent prior to any study related procedures;

- Subjects must be ≥ 21 and ≤ 85 years of age;

- Subjects must have known or suspected CAD documented by ≥2 segments of reversible
perfusion abnormalities on a SPECT (MPI)study

Exclusion Criteria

- Any clinically significant acute or unstable physical or psychological disease judged
by the investigators based on medical history or screening physical examination;

- Blood pressure over 180/100mmHg

- Acute changes in comparison to most recent ECG;

- Recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident
(CVA), CABG or PCI

- Any pacemaker or defibrillator implanted within the last three months;

- Inability to remain in camera for approximately 60 minutes

- Bronchospasm

- Serum creatinine > 2 mg/dL;

- Cancer patients who have received chemotherapy or radiation therapy within the past 60
days.

- Any exposure to any investigational drug(s) or medical device(s) within four (4) weeks
prior to imaging study;

- Any physical or psychological disease judged by the investigators to be incompatible
with the study, based on medical history or screening physical examination.

- NYHA Class III or IV Congestive heart failure;

- Subject has symptomatic hypotension

- Allergic or intolerant to aminophylline, nitroglycerin or metoprolol

- Allergic or intolerant to regadenoson or any of its excipients

- Prior participants in the study.

- Female subjects only: Positive serum and/or urine 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
BFPET administration.