development of 1-day rest/stress cardiac pet perfusion imaging protocol of bms747158

Conditions: Ischemia

Summary: the main purpose of this study is to get more information on using bms747158 (the study drug),a drug with small amounts of radioactivity to allow for heart imaging, during a pet scan which can then be compared to other images such as spect. the safety and quality of images will be studied.

the primary objectives of this study are: * to acquire data for the development of one-day rest/stress cardiac pet perfusion imaging protocols for bms747158 with comparable diagnostic image quality to a two-day rest/stress pet protocol * to assess the safety of multiple doses of bms747158 the secondary objectives of this study are: * to assess pet imaging parameters and image quality following administration of bms747158 at rest and at stress (pharmacologic or exercise) same day (at different time intervals) and 16-48 hours after the rest injection * to assess feasibility of gated cardiac pet imaging with bms747158 for left ventricular function assessment * to assess agreement of one and two day rest/stress pet imaging with bms747158 in patients with reversible ischemia with rest/stress single photon emission computed tomography (spect) imaging * to perform a preliminary assessment of the diagnostic accuracy of one-day and two-day rest/stress pet perfusion imaging with bms747158 as compared with invasive coronary angiography or computed tomography angiography (cta) for detection of

Eligibility criteria:
inclusion criteria: * provide signed ic prior to undergoing any study procedures * be male or nonpregnant female, between the ages of 18 to 75 years, inclusive * have:a rest/stress spect imaging study (either exercise or pharmacologic stress) within 21 days of enrollment, using 99mtc-labeled tracers and showing reversible ischemia * female patients must: * be nonlactating, * no longer have child-bearing potential, either because they are post-menopausal (defined as amenorrhea ≥ 12 consecutive months, or because they have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) exclusion criteria: * presence of any condition that may disrupt and/or increase permeability of the bbb, including multiple sclerosis, alzheimer's disease, parkinson's disease, acute central nervous system (cns) infection, cns tumor, autoimmune disease affecting the cns, or cns inflammatory * current significant illness, pathology or physical examination or vital signs measurement-findings that could potentiate any adverse pharmacological event associated with a vasodilatory drug or any pathology that, in the opinion of the investigator, might confound the interpretation of the results of the study * known hypersensitivity to adenosine, dipyridamole or aminophylline * presence of any contraindications to exercise stress testing * history of new york heart association class iii or iv congestive heart failure (chf) * any major surgery within 4 weeks prior to enrollment or planned within 2 weeks following completion of the 2-week telephone follow-up assessment * inability to tolerate iv medication. * history of drug or alcohol abuse within the last year * participation in any investigational drug, device, or placebo study within 6 months prior to study enrollment

Keywords: myocardial perfusion pet imaging spect imaging coronary artery disease subjects that are male and nonpregnant female patients presenting with reversible ischemia as characterized by a rest/stress spect imaging study using technetium(99mtc)-labeled tracers