Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158
Condition: Ischemia
MeSH terms: Ischemia
Intervention: BMS747158
Intervention description: dosages at rest and at stress were not to exceed a total of 14 mCi.
Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period.
Cohort 2: Patients to recieve IV bolus injections of BMS747158:
For the Pharmacologic (Adenosine) Stress:
Doses at rest were to range between 2.9 and 3.4 mCi.
Doses under stress were to be a factor of 2.0 to 2.4 greater than the rest dose, resulting in a range of stress doses between 5.8 and 8.2 mCi.
For the Exercise Stress:
Doses at rest were to range between 1.7 and 2.0 mCi.
Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
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

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.
    

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