Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/21/2016 |
Start Date: | January 2009 |
End Date: | June 2010 |
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
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.
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
- 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
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
We found this trial at
24
sites
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Saint Louis University Saint Louis University is a Catholic, Jesuit institution with campuses in St....
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