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This is a single-center study of subjects undergoing clinically indicated heart scans for evaluation of known or suspected heart disease. We will also include 10 healthy subjects without known heart disease. We would like to study stress testing of the heart using exercise and a medication called regadenoson. Imaging of the heart will be performed.
Regadenoson is stress agent approved by the FDA for use with myocardial perfusion imaging with technetium-99m single photon emission computed tomography (SPECT) in patients that are unable to exercise adequately. We would like to study Regadenoson in conjunction with Exercise Rubidium-82 positron emission tomography myocardial perfusion imaging (PET MPI). Regadenoson is not approved by FDA for use with Rubidium-82 PET MPI. Also, we would like to study a novel stress protocol of Regadenoson combined with symptom limited exercise stress (not FDA approved).
The objectives of this study are to assess the tolerability and safety of combined symptom limited exercise stress test with Lexiscan (Lexercise PET) compared to Lexiscan alone (Lexiscan PET), to assess image quality of Lexercise compared to Lexiscan PET and to compare relative and absolute myocardial perfusion imaging with Lexercise compared to Lexiscan PET to identify CAD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regadenoson (Lexiscan) | Active Comparator | Regadenoson Rubidium-82 Positron Emission Tomography |
|
| Exercise + Regadenoson (Lexercise) | Experimental | Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise plus Regadenoson (Lexercise) | Drug | Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Combined Exercise and Regadenoson Stress |
| Day of the research scan during the stress test |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality: Heart to Liver Ratio of Counts | Sub-diaphragmatic activity: Heart to Liver Ratio was measured on the rubidium-82 and N-13 ammonia scans. Since this measure is a ratio it has no units. Mean and Standard Deviation of Ratio is reported for each group. This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects. | Week 1 (day of the clinical scan), and Week 2 (day of the research scan) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharmila Dorbala, MBBS | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Womens' Hospital | Boston | Massachusetts | 02421 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15837254 | Background | Chow BJ, Ananthasubramaniam K, dekemp RA, Dalipaj MM, Beanlands RS, Ruddy TD. Comparison of treadmill exercise versus dipyridamole stress with myocardial perfusion imaging using rubidium-82 positron emission tomography. J Am Coll Cardiol. 2005 Apr 19;45(8):1227-34. doi: 10.1016/j.jacc.2005.01.016. | |
| 17372188 | Background |
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43 subjects consented for the study and 41 subjects completed the study. One subject did not come for the study procedures. One subject could not cooperate with imaging and was moving during the rest scan. Regadenoson scan was not performed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regadenoson | Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson Rubidium-82 Positron Emission Tomography |
| FG001 | Exercise + Regadenoson | Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regadenoson | Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson: Regadenoson Rubidium-82 Positron Emission Tomography |
| BG001 | Exercise + Regadenoson | Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safety and Tolerability of Combined Exercise and Regadenoson Stress |
| Radiation dose to staff was not measured due to logistical difficulties.Three subjects had blood pressure changes in the Regadenoson (Lexiscan) arm; 3 subjects showed ischemic ECG changes in the exercise + regadenoson (Lexercise) arm; and, none of the subjects showed abnormal troponin levels. | Posted | Count of Participants | Participants | Day of the research scan during the stress test |
|
Adverse events were collected on the day of the research study which was in week 2 for most patients.
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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 | Regadenoson (Lexiscan) | Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharmila Dorbala | Brigham and Women's Hospital | 617-732-6215 | sdorbala@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2016 | Jun 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C430916 | regadenoson |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Regadenoson (Lexiscan) | Drug | Regadenoson Rubidium-82 Positron Emission Tomography |
|
| Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET | Left ventricular ejection fraction (LVEF) at stress was measured at Stress scan 1 (regadenoson) and Stress scan 2 (regadenoson or exercise + regadenoson). This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects. | Week 1 (day of the clinical scan), and Week 2 (day of the research scan) |
| Peak Stress Myocardial Blood Flow | Myocardial Blood Flow Measured at Peak Hyperemia With Regadenoson or Immediately After Exercise + Regadenoson This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects. | Week 1 (day of the clinical scan), and Week 2 (day of the research scan) |
| Di Carli MF, Hachamovitch R. New technology for noninvasive evaluation of coronary artery disease. Circulation. 2007 Mar 20;115(11):1464-80. doi: 10.1161/CIRCULATIONAHA.106.629808. No abstract available. |
| 12975245 | Background | Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, O'Gara PT, Carabello BA, Russell RO Jr, Cerqueira MD, St John Sutton MG, DeMaria AN, Udelson JE, Kennedy JW, Verani MS, Williams KA, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Society for Nuclear Cardiology. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). Circulation. 2003 Sep 16;108(11):1404-18. doi: 10.1161/01.CIR.0000080946.42225.4D. No abstract available. |
| 16412870 | Background | Chow BJ, Beanlands RS, Lee A, DaSilva JN, deKemp RA, Alkahtani A, Ruddy TD. Treadmill exercise produces larger perfusion defects than dipyridamole stress N-13 ammonia positron emission tomography. J Am Coll Cardiol. 2006 Jan 17;47(2):411-6. doi: 10.1016/j.jacc.2005.09.027. |
| 17314342 | Background | Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. doi: 10.1056/NEJMra061889. No abstract available. |
| 16085581 | Background | El Fakhri G, Sitek A, Guerin B, Kijewski MF, Di Carli MF, Moore SC. Quantitative dynamic cardiac 82Rb PET using generalized factor and compartment analyses. J Nucl Med. 2005 Aug;46(8):1264-71. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Exercise + Regadenoson (Lexercise) | Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography |
|
|
| Secondary | Image Quality: Heart to Liver Ratio of Counts | Sub-diaphragmatic activity: Heart to Liver Ratio was measured on the rubidium-82 and N-13 ammonia scans. Since this measure is a ratio it has no units. Mean and Standard Deviation of Ratio is reported for each group. This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects. | Posted | Mean | Standard Deviation | mean ratio | Week 1 (day of the clinical scan), and Week 2 (day of the research scan) |
|
|
|
| Secondary | Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET | Left ventricular ejection fraction (LVEF) at stress was measured at Stress scan 1 (regadenoson) and Stress scan 2 (regadenoson or exercise + regadenoson). This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects. | Posted | Mean | Standard Deviation | percentage of LVEF | Week 1 (day of the clinical scan), and Week 2 (day of the research scan) |
|
|
|
| Secondary | Peak Stress Myocardial Blood Flow | Myocardial Blood Flow Measured at Peak Hyperemia With Regadenoson or Immediately After Exercise + Regadenoson This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects. | Myocardial blood flow could not be accurately measured in one subject from each arm. Therefore we report information on 10/11 subjects in Regadenoson arm and 29/30 subjects in the Exercise + Regadenoson arm. | Posted | Mean | Standard Deviation | mL/gm/min | Week 1 (day of the clinical scan), and Week 2 (day of the research scan) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Exercise + Regadenoson (Lexiscan) | Exercise plus Regadenoson (Lexiscan) Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography | 0 | 30 | 0 | 30 | 0 | 30 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001519 | Behavior |