drugset / Trial / NCT00849108
Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158
Non-randomizedParallel-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2009-01
- Primary completion
- 2010-06
- Completion
- 2010-06
Outcome
Mixed primary results
registry NUMBER Cohort 2 Efficacy/Safety: PET MPI: 0.769 Proportion of True Positive Cases NCT00849108 ↗
registry NUMBER Cohort 2 Efficacy/Safety: SPECT MPI: 0.596 Proportion of True Positive Cases NCT00849108 ↗
registry p = 0.02; sensitivity 0.769 (95% CI 0.655 to 0.884); McNemar NCT00849108 ↗
registry p = 0.317; PET specificity 0.877 (95% CI 0.801 to 0.952); McNemar NCT00849108 ↗
Publications
- Background Bateman TM. Cardiac positron emission tomography and the role of adenosine pharmacologic stress. Am J Cardiol. 2004 Jul 22;94(2A):19D-24D; discussion 24D-25D. doi: 10.1016/j.amjcard.2004.04.013.
- Background Beller GA. First annual Mario S. Verani, MD, Memorial lecture: clinical value of myocardial perfusion imaging in coronary artery disease. J Nucl Cardiol. 2003 Sep-Oct;10(5):529-42. doi: 10.1016/s1071-3581(03)00655-x.
- Background Beller GA, Bergmann SR. Myocardial perfusion imaging agents: SPECT and PET. J Nucl Cardiol. 2004 Jan-Feb;11(1):71-86. doi: 10.1016/j.nuclcard.2003.12.002. No abstract available.
- Background Beller GA, Zaret BL. Contributions of nuclear cardiology to diagnosis and prognosis of patients with coronary artery disease. Circulation. 2000 Mar 28;101(12):1465-78. doi: 10.1161/01.cir.101.12.1465. No abstract available.
- Background Cerqueira MD, Verani MS, Schwaiger M, Heo J, Iskandrian AS. Safety profile of adenosine stress perfusion imaging: results from the Adenoscan Multicenter Trial Registry. J Am Coll Cardiol. 1994 Feb;23(2):384-9. doi: 10.1016/0735-1097(94)90424-3.
- Background Guideri F, Ferber D, Galgano G, Isidori S, Blardi P, Pasini FL, Di Perri T. QTc interval prolongation during infusion with dipyridamole or adenosine. Int J Cardiol. 1995 Jan 27;48(1):67-73. doi: 10.1016/0167-5273(94)02209-2.
- Background Glover DK, Gropler RJ. Journey to find the ideal PET flow tracer for clinical use: are we there yet? J Nucl Cardiol. 2007 Nov-Dec;14(6):765-8. doi: 10.1016/j.nuclcard.2007.09.019. No abstract available.
- Background Henzlova MJ, Cerqueira MD, Mahmarian JJ, Yao SS; Quality Assurance Committee of the American Society of Nuclear Cardiology. Stress protocols and tracers. J Nucl Cardiol. 2006 Nov;13(6):e80-90. doi: 10.1016/j.nuclcard.2006.08.011. No abstract available.
- Background Miyamoto MI, Vernotico SL, Majmundar H, Thomas GS. Pharmacologic stress myocardial perfusion imaging: a practical approach. J Nucl Cardiol. 2007 Apr;14(2):250-5. doi: 10.1016/j.nuclcard.2007.01.006. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BMS747158 | Diagnostic / imaging agent | 1.7 unknown | Intravenous |
| Subject | BMS747158 | Diagnostic / imaging agent | 2 unknown | Intravenous |
| Subject | BMS747158 | Diagnostic / imaging agent | 2.9 unknown | Intravenous |
| Subject | BMS747158 | Diagnostic / imaging agent | 3.4 unknown | Intravenous |
| Subject | BMS747158 | Diagnostic / imaging agent | 5.1 unknown | Intravenous |
| Subject | BMS747158 | Diagnostic / imaging agent | 5.8 unknown | Intravenous |
| Subject | BMS747158 | Diagnostic / imaging agent | 7.2 unknown | Intravenous |
| Subject | BMS747158 | Diagnostic / imaging agent | 8.2 unknown | Intravenous |