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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.
The primary objectives of this study are:
The secondary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: dose range and dose interval | Experimental | 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. |
|
| Cohort 2: Pharm&exercise stress Efficacy | Experimental | Patients to receive 2 IV bolus injections of BMS747158:1 at rest and 1 at stress For the Pharmacologic (Adenosine) Stress:
For the Exercise Stress:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS747158 | Drug | 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:
For the Exercise Stress:
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product | The rest flurpiridaz dose to be used for subsequent efficacy studies was determined by a modeling method that simulated a range of injected doses using a single fixed injected dose at rest in each subject and a range of acquisition durations. From this, a dose acquisition time product (DATP was determined for each subject that specified the minimal dose for a given acquisition duration that yielded an image in that subject that was negligibly affected by photon counting statistics. Descriptive statistics were used to identify an appropriate rest dose for the population. No other statistical tests were performed | Dosing visit |
| Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Sensitivity (SN) vs SPECT MPI Sensitivity | Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by sensitivity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard. | Dosing visit |
| Cohort 1: Determination of Ratio of Stress Dose to Rest Dose | The stress flurpiridaz dose for subsequent same-day rest-stress efficacy studies was determined as a multiple of the rest dose by computer modeling. Images derived only from rest flurpiridaz administration were blended using image analysis with images derived only from administration of flurpiridaz following exercise or adenosine stress. The blending fraction that resulted in negligible change in reader interpretation of defect severity was determined for each subject. The minimum value that met this criterion for all subjects was used to calculate the ratio of the stress dose to the rest dose as a function of the delay between administration of the two doses for both adenosine stress and exercise stress separately. No statistical analysis was performed. | Dosing visit |
| Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Specificity (SP) vs SPECT MPI Specificity |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cesare Orlandi, MD | Lantheus Medical Imaging | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silicon Valley Medical Imaging | Fremont | California | 94538 | United States | ||
| Scripps Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15261128 | 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. | |
| 14569247 | 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. |
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Cohort 1: Patients showing a mild to severe reversible perfusion defect on a qualifying SPECT MPI study were considered eligible for the study Cohort 2: Patients with known or suspected cornary artery disease who presented with a broad spectrum of pre-test likelihood of CAD(very low/low, to high likelihood)were considered eligible for the study.
Cohort 1 enrolled 33 patients across 3 clinical sites. Dosing for Cohort 1 was initiated January 2009.
Cohort 2 enrolled 143 patients across 21 clinical sites. Dosing for Cohort 2 was initiated July 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 Dose Ranging and Dose Interval | Patients received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period |
| FG001 | Cohort 2 Preliminary Efficacy Pharmacologic Stress |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cohort 1 Dose Ranging and Dose Interval |
|
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Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by specificity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.
| Dosing Visit |
| La Jolla |
| California |
| 92037 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90095 | United States |
| UCLA Medical Plaza | Los Angeles | California | 90095 | United States |
| Radiological Associates of Sacramento | Sacramento | California | 95816 | United States |
| VA Healthcare System San Diego | San Diego | California | 92161 | United States |
| Hartford Hospital | Hartford | Connecticut | 05102-5037 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Primary Care Cardiology Research, Inc | Ayer | Massachusetts | 01432 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Cardiovascular Consultants | Kansas City | Missouri | 64101 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Medicine and Dentistry of New Jersey | Newark | New Jersey | 07107 | United States |
| Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| University Hospital Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Midwest Cardiology Research Foundation | Columbus | Ohio | 43214 | United States |
| Mountain States Health Alliance | Johnson City | Tennessee | 37604 | United States |
| East Tennessee Clinical Research Institute | Knoxville | Tennessee | 27934 | United States |
| 14752475 | 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. |
| 10736294 | 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. |
| 8294691 | 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. |
| 7744540 | 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. |
| 18022101 | 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. |
| 17174798 | 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. |
| 17386388 | 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. |
Patients received 2 injections of BMS747158: 1 at rest and 1 at Pharmacologic stress, over a 1-day period. |
| COMPLETED |
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| NOT COMPLETED |
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| Cohort 2 Efficacy |
|
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Intent to treat population Cohort 1 N=33; Cohort 2 N=125 Safety population; Cohort 1 N=33; Cohort 2 N=143
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 Dose Ranging and Dose Interval | Patients received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period |
| BG001 | Cohort 2: Pharm Stress | Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at pharmacologic stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. |
| BG002 | Cohort 2: Efficacy Exercise Stress | Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at exercise stress over a 1-day period. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product | The rest flurpiridaz dose to be used for subsequent efficacy studies was determined by a modeling method that simulated a range of injected doses using a single fixed injected dose at rest in each subject and a range of acquisition durations. From this, a dose acquisition time product (DATP was determined for each subject that specified the minimal dose for a given acquisition duration that yielded an image in that subject that was negligibly affected by photon counting statistics. Descriptive statistics were used to identify an appropriate rest dose for the population. No other statistical tests were performed | Intent to treat, received at least one rest dose of BMS 747158 | Posted | Mean | Standard Deviation | MBq X Minutes | Dosing visit |
|
|
| |||||||||||||||||||||||||
| Primary | Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Sensitivity (SN) vs SPECT MPI Sensitivity | Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by sensitivity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard. | intent to treat, received at least one dose of BMS747158 | Posted | Number | Proportion of True Positive Cases | Dosing visit |
|
| |||||||||||||||||||||||||||
| Primary | Cohort 1: Determination of Ratio of Stress Dose to Rest Dose | The stress flurpiridaz dose for subsequent same-day rest-stress efficacy studies was determined as a multiple of the rest dose by computer modeling. Images derived only from rest flurpiridaz administration were blended using image analysis with images derived only from administration of flurpiridaz following exercise or adenosine stress. The blending fraction that resulted in negligible change in reader interpretation of defect severity was determined for each subject. The minimum value that met this criterion for all subjects was used to calculate the ratio of the stress dose to the rest dose as a function of the delay between administration of the two doses for both adenosine stress and exercise stress separately. No statistical analysis was performed. | Subjects with demonstrated partially or completely reversible defects on prior SPECT who received at least one stress and one rest dose of flurpiridaz F 18, on separate days. | Posted | Number | Fraction of rest added to stress image | Dosing visit |
|
| |||||||||||||||||||||||||||
| Primary | Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Specificity (SP) vs SPECT MPI Specificity | Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by specificity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard. | intent to treat, received at least one dose of BMS747158 | Posted | Number | Proportion of True Negative Cases | Dosing Visit |
|
|
Cohort 1: Adverse event monitoring was initiated on Study Day 1 at time of rest dose and conitnued through 2-week follow up Cohort 2: Adverse event monitoring was intiatied on Study Day 1 at time of rest dose and continued through 1-week follow up
Safety data were not combined and are reported by Cohort
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 33 | 21 | 33 | ||
| EG001 | Cohort 2: Efficacy in Pharm Stress | Patients receive 2 IV injections of BMS747158:at rest and stress For the Pharmacologic (Adenosine) Stress:
For the Exercise Stress:
| 2 | 143 | 61 | 143 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment | Right Knee Effusion |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment | Progressively Worsening Dizziness |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment | Progressively worsening Hypertension |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Feeling Hot | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| INfluenza Like Illness | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Non Cardiac Chest Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Musculosketetal Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Claustrophobia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cesare Orlandi, MD, Chief Medical Officer | Lantheus Medical Imaging | 978-671-8686 | cesare.orlandi@lantheus.com |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C525920 | BMS 747158-02 |
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| Between 18 and 65 years |
|
| >=65 years |
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| Male |
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