Regadenoson-stress myocardial CT perfusion and single-photon emission CT: Rationale,design, and acquisition methods of a prospective,multicenter, multivendor comparison |
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| Affiliation: | 1. Baptist Hospital of Miami and Baptist Cardiac and Vascular Institute, 8900 North Kendall Dr, Miami, FL 33176, USA;2. Astellas Scientific and Medical Affairs, Inc., Northbrook, IL, USA;3. Astellas Pharma Global Development, Inc., Northbrook, IL, USA;4. Division of Cardiology, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA;1. Department of Cardiology, Takase Clinic, 885-2 Minami-orui, Takasaki 370-0036, Japan;2. Department of Radiological Technology, Takase Clinic, 885-2 Minami-orui, Takasaki 370-0036, Japan;3. Applied Imaging Science Laboratory, Department of Radiology, Brigham and Women''s Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA;1. Department of Cardiology, Takase Clinic, Takasaki 370-0036, Japan;2. Department of Cardiology, Juntendo University, Tokyo 113-8431, Japan;3. Department of Radiological Technology, Takase Clinic, Takasaki 370-0036, Japan;4. Applied Imaging Science Laboratory, Department of Radiology, Brigham and Women''s Hospital and Harvard Medical School, 75 Francis St, Boston, MA 02115, USA;1. Department of Clinical Radiology, Ludwig-Maximilians-University, Klinikum Grosshadern, Munich, Germany;2. Munich Heart Alliance, Munich, Germany;3. Department of Cardiology, Ludwig-Maximilians-University, Klinikum Grosshadern, Munich, Germany;1. Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, Baltimore, MD, USA;2. Division of Internal Medicine, Virginia Commonwealth University Medical Center-Medical College of Virginia, 1200 E Broad Street, Richmond, VA 23298, USA;3. Division of Cardiology, St. Luke''s–Roosevelt Hospital Center, Columbia College of Physicians and Surgeons, New York, NY, USA;4. Division of Cardiology, Danbury Hospital, Danbury, CT, USA;5. Division of Cardiology, Emory University, Atlanta, GA, USA;6. Princeton Longevity Center, Princeton, NJ, USA;7. Tennessee Heart and Vascular Center, Hendersonville, TN, USA;8. Cedars–Sinai Medical Center and the Cedars–Sinai Heart Institute, Los Angeles, CA, USA;9. Division of Cardiology, Mazankowski Alberta Heart Institute, Edmonton, AB, Canada;10. Center for Prevention and Wellness Research, Baptist Health Medical Group, Miami Beach, FL, USA;11. Division of Cardiology, Los Angeles Biomedical Research Institute at Harbor–UCLA, Torrance, CA, USA;1. Department of Diagnostic Radiology, University Hospital Freiburg, Freiburg, Germany;2. Department of Cardiology Namborn Hospital, Namborn, Australia;3. Department of Cardiology, University of Erlangen, Erlangen, Germany;4. Department of Cardiology, McGill University, Montreal, QB, Canada;5. Department of Cardiovascular Surgery, Munich Heart Center, Munich, Germany;6. Institute for Cardiovascular Imaging, Weill-Cornell Medical College, New York, NY, USA;7. Division of Cardiovascular Radiology, University Heart-Center Freiburg–Bad Krozingen, Germany;8. Department of Radiology, St. Paul''s Hospital, University of British Columbia, 1081 Burrard St, Vancouver, BC V6S 1Y6, Canada;1. Department of Radiology, Cardiac CT/MR Unit, Rouen University Hospital, 1 rue de Germont, 76031 Rouen, France;2. Inserm U1096, Rouen, France;3. University of Rouen, Institute for Research and Innovation in Biomedicine, Rouen, France;4. Department of Cardiology, Rouen University Hospital, Rouen, France |
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| Abstract: | Pharmacologic stress myocardial CT perfusion (CTP) has been reported to be a viable imaging modality for detection of myocardial ischemia compared with single-photon emission CT (SPECT) in several single-center studies. However, regadenoson-stress CTP has not previously been compared with SPECT in a multicenter, multivendor study. The rationale and design of a phase 2, randomized, cross-over study of regadenoson-stress myocardial perfusion imaging by CTP compared with SPECT are described herein. The study will be conducted at approximately 25 sites by using 6 different CT scanner models, including 64-, 128-, 256-, and 320-slice systems. Subjects with known/suspected coronary artery disease will be randomly assigned to 1 of 2 imaging procedure sequences; rest and regadenoson-stress SPECT on day 1, then regadenoson-stress CTP and rest CTP/coronary CT angiography (same acquisition) on day 2; or regadenoson-stress CTP and rest CTP/CT angiography on day 1, then rest and regadenoson-stress SPECT on day 2. The prespecified primary analysis examines the agreement rate between CTP and SPECT for detecting or excluding ischemia (≥2 or 0–1 reversible defects, respectively), as assessed by 3 independent blinded readers for each modality. Non-inferiority will be indicated if the lower boundary of the 95% CI for the agreement rate is within 0.15 of 0.78 (the observed agreement rate in the regadenoson pivotal trials). The protocol described herein will support the first evaluation of regadenoson-stress CTP by using multiple scanner types compared with SPECT. |
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| Keywords: | Regadenoson Cardiovascular imaging Pharmacologic stress CT perfusion imaging Single-photon emission CT Study design |
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