title: Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison.
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.
authors: Baptist Hospital of Miami and Baptist Cardiac and Vascular Institute, 8900 North Kendall Dr, Miami, FL 33176, USA. Electronic address: rcury@baptisthealth.net.
authors: Ricardo C
authors: RC
authors: Cury
authors: Astellas Scientific and Medical Affairs, Inc., Northbrook, IL, USA.
authors: Therese M
authors: TM
authors: Kitt
authors: Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
authors: Kathleen
authors: K
authors: Feaheny
authors: Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
authors: Jamie
authors: J
authors: Akin
authors: Division of Cardiology, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.
authors: Richard T
authors: RT
authors: George
mesh_terms: D003324:Coronary Artery Disease / Q000150:complications / Q000175:diagnosis*; D005080:Exercise Test / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D064847:Multimodal Imaging / Q000379:methods; D009203:Myocardial Infarction / Q000175:diagnosis* / Q000209:etiology; D055414:Myocardial Perfusion Imaging / Q000379:methods; D011446:Prospective Studies; D011687:Purines / Q000009:adverse effects; D011720:Pyrazoles / Q000009:adverse effects; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods*; D014057:Tomography, X-Ray Computed / Q000379:methods*; D014481:United States; D014665:Vasodilator Agents / Q000009:adverse effects
chemical_list: D011687:Purines; D011720:Pyrazoles; D014665:Vasodilator Agents; C430916:regadenoson
keywords: CT perfusion imaging; Cardiovascular imaging; Pharmacologic stress; Regadenoson; Single-photon emission CT; Study design