At a glance
ClinicalIndex Comparison Record- ✓Age 18–75 years, male or non-pregnant female
- ✓Prior rest/stress SPECT imaging study within 21 days showing reversible ischemia using 99mTc-labeled tracers
- ✓Female patients must be non-lactating and either post-menopausal (≥12 consecutive months amenorrhea) or surgically sterilized
- ✕Presence of conditions that disrupt/increase blood–brain barrier permeability: multiple sclerosis, Alzheimer's disease, Parkinson's disease, acute CNS infection, CNS tumor, CNS autoimmune disease, or CNS inflammatory condition
- ✕Known hypersensitivity to adenosine, dipyridamole, or aminophylline
- ✕History of New York Heart Association Class III or IV Congestive Heart Failure
- ✕Any major surgery within 4 weeks prior to enrollment or planned within 2 weeks following completion of follow-up assessment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-Label, Randomized Multicenter Study for the Development of One-Day Rest/Stress Cardiac Positron Emission Tomography (PET) Perfusion Imaging Protocols of BMS747158
In Brief
A Phase 2 clinical trial evaluating BMS747158 for Ischemia. Completed, enrolled 176 participants across 24 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.