Rationale and design of the RAPID-WATER-FLOW trial: Radiolabeled perfusion to identify coronary artery disease using water to evaluate responses of myocardial FLOW.

Autor:	Di Carli MF; Departments of Medicine and Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: mdicarli@bwh.harvard.edu., Gormsen LC; Department of Nuclear Medicine & PET Center, Aarhus University Hospital, Denmark., Chareonthaitawee P; Departments of Radiology and Medicine, Mayo Clinic, Rochester, MN, USA., Johnson GB; Departments of Radiology and Medicine, Mayo Clinic, Rochester, MN, USA., Beanlands R; National Cardiac PET Centre, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Canada., DeKemp R; National Cardiac PET Centre, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Canada., Schindler T; Department of Radiology, Washington University, St Louis, MO, USA., Gropler R; Department of Radiology, Washington University, St Louis, MO, USA., Kulkarni H; BAMF Health, Grand Rapids, MI, USA., McNeely P; Department of Radiology, University of Iowa, Iowa City, IA, USA., Soman P; Departments of Medicine and Radiology, University of Pittsburgh, Pittsburgh, PA, USA., Oz O; Department of Radiology, UT Southwestern, Dallas, TX, USA., Zaha V; Department of Radiology, UT Southwestern, Dallas, TX, USA., Sorensen J; PET Center, Uppsala University Hospital, Uppsala, Sweden., Harms H; MedTrace, Agern Alle 5A, 2970 Hørsholm, Denmark., Orlandi C; MedTrace, Agern Alle 5A, 2970 Hørsholm, Denmark., Vandenbroucke E; MedTrace, Agern Alle 5A, 2970 Hørsholm, Denmark., Udelson J; Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, MA, USA.
Jazyk:	angličtina
Zdroj:	Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology [J Nucl Cardiol] 2024 Jan; Vol. 31, pp. 101779. Date of Electronic Publication: 2023 Dec 05.
DOI:	10.1016/j.nuclcard.2023.101779
Abstrakt:	Objectives: The objective of this study was to determine the diagnostic performance of 15 O-water positron emission tomography (PET) myocardial perfusion imaging to detect coronary artery disease (CAD) using the truth-standard of invasive coronary angiography (ICA) with fractional flow reserve (FFR) or instantaneous wave-Free Ratio (iFR) or coronary computed tomography angiogram (CCTA). Background: 15 O-water has a very high first-pass extraction that allows accurate quantification of myocardial blood flow and detection of flow-limiting CAD. However, the need for an on-site cyclotron and lack of automated production at the point of care and relatively complex image analysis protocol has limited its clinical use to date. Methods: The RAPID WATER FLOW study is an open-label, multicenter, prospective investigation of the accuracy of 15 O-water PET to detect obstructive angiographic and physiologically significant stenosis in patients with suspected CAD. The study will include the use of an automated system for producing, dosing, and injecting 15 O-water and enrolling approximately 215 individuals with suspected CAD at approximately 10 study sites in North America and Europe. The primary endpoint of the study is the diagnostic sensitivity and specificity of the 15 O-water PET study using the truth-standard of ICA with FFR or iFR to determine flow-limiting stenosis, or CCTA to rule out CAD and incorporating a quantitative analytic platform developed for the 15 O-water PET acquisitions. Sensitivity and specificity are to be considered positive if the lower bound of the 95% confidence interval is superior to the threshold of 60% for both, consistent with prior registration studies. Subgroup analyses include assessments of diagnostic sensitivity, specificity, and accuracy in female, obese, and diabetic individuals, as well as in those with multivessel disease. All enrolled individuals will be followed for adverse and serious adverse events for up to 32 hours after the index PET scan. The study will have >90% power (one-sided test, α = 0.025) to test the hypothesis that sensitivity and specificity of 15 O-water PET are both >60%. Conclusions: The RAPID WATER FLOW study is a prospective, multicenter study to determine the diagnostic sensitivity and specificity of 15 O-water PET as compared to ICA with FFR/iFR or CCTA. This study will introduce several novel aspects to imaging registration studies, including a more relevant truth standard incorporating invasive physiologic indexes, coronary CTA to qualify normal individuals for eligibility, and a more quantitative approach to image analysis than has been done in prior pivotal studies. Clinical Trial Registration Information: Clinical-Trials.gov (#NCT05134012). (Copyright © 2023 American Society of Nuclear Cardiology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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