Regadenoson-stress myocardial CT perfusion and single-photon emission CT: Rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison

Ricardo C. Cury, Therese M. Kitt, Kathleen Feaheny, Jamie Akin, Richard T. George

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)2-12
Number of pages11
JournalJournal of Cardiovascular Computed Tomography
Volume8
Issue number1
DOIs
Publication statusPublished - Jan 2014

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Keywords

  • Cardiovascular imaging
  • CT perfusion imaging
  • Pharmacologic stress
  • Regadenoson
  • Single-photon emission CT
  • Study design

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

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