Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lantheus Medical Imaging

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