Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158
NCT ID: NCT00849108
Last Updated: 2015-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2009-01-31
2010-06-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort 1: dose range and dose interval
Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period.
BMS747158
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.
Cohort 2: Pharm&exercise stress Efficacy
Patients to receive 2 IV bolus injections of BMS747158:1 at rest and 1 at stress
For the Pharmacologic (Adenosine) Stress:
* Doses at rest to range between 2.9 and 3.4 mCi.
* Doses under stress 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.
BMS747158
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.
Interventions
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BMS747158
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Lantheus Medical Imaging
INDUSTRY
Responsible Party
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Principal Investigators
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Cesare Orlandi, MD
Role: STUDY_DIRECTOR
Lantheus Medical Imaging
Locations
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Silicon Valley Medical Imaging
Fremont, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Medical Plaza
Los Angeles, California, United States
Radiological Associates of Sacramento
Sacramento, California, United States
VA Healthcare System San Diego
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Emory University Hospital
Atlanta, Georgia, United States
Primary Care Cardiology Research, Inc
Ayer, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Cardiovascular Consultants
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
Holy Name Hospital
Teaneck, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
University Hospital Case Medical Center
Cleveland, Ohio, United States
Midwest Cardiology Research Foundation
Columbus, Ohio, United States
Mountain States Health Alliance
Johnson City, Tennessee, United States
East Tennessee Clinical Research Institute
Knoxville, Tennessee, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BMS747158-201
Identifier Type: -
Identifier Source: org_study_id
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