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Rationale and design of the RAPID-WATER-FLOW trial: Radiolabeled perfusion to identify coronary artery disease using water to evaluate responses of myocardial FLOW
Journal article   Open access   Peer reviewed

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

Marcelo F Di Carli, Lars C Gormsen, Panithaya Chareonthaitawee, Geoffrey B Johnson, Rob Beanlands, Rob DeKemp, Thomas Schindler, Robert Gropler, Harshad Kulkarni, Parren McNeely, …
Journal of nuclear cardiology, Vol.31, 101779
12/05/2023
DOI: 10.1016/j.nuclcard.2023.101779
PMID: 38215598
url
https://doi.org/10.1016/j.nuclcard.2023.101779View
Published (Version of record) Open Access

Abstract

The objective of this study was to determine the diagnostic performance of 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). 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. The RAPID WATER FLOW study is an open-label, multicenter, prospective investigation of the accuracy of 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 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 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 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 O-water PET are both >60%. The RAPID WATER FLOW study is a prospective, multicenter study to determine the diagnostic sensitivity and specificity of 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-Trials.gov (#NCT05134012).
 Coronary artery disease Positron emission tomography Myocardial perfusion imaging

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