Article Text
Abstract
Introduction Anatomic stenosis evaluation on coronary CT angiography (CCTA) lacks specificity in indicating the functional significance of a stenosis. Recent developments in CT techniques (including dual-layer spectral detector CT [SDCT] and static stress CT perfusion [CTP]) and image analyses (including fractional flow reserve [FFR] derived from CCTA images [FFRCT] and deep learning analysis [DL]) are potential strategies to increase the specificity of CCTA by combining both anatomical and functional information in one investigation. The aim of the current study is to assess the diagnostic performance of (combinations of) SDCT, CTP, FFRCT and DL for the identification of functionally significant coronary artery stenosis.
Methods and analysis Seventy-five patients aged 18 years and older with stable angina and known coronary artery disease and scheduled to undergo clinically indicated invasive FFR will be enrolled. All subjects will undergo the following SDCT scans: coronary calcium scoring, static stress CTP, rest CCTA and if indicated (history of myocardial infarction) a delayed enhancement acquisition. Invasive FFR of ≤0.80, measured within 30 days after the SDCT scans, will be used as reference to indicate a functionally significant stenosis. The primary study endpoint is the diagnostic performance of SDCT (including CTP) for the identification of functionally significant coronary artery stenosis. Secondary study endpoint is the diagnostic performance of SDCT, CTP, FFRCT and DL separately and combined for the identification of functionally significant coronary artery stenosis.
Ethics and dissemination Ethical approval was obtained. All subjects will provide written informed consent. Study findings will be disseminated through peer-reviewed conference presentations and journal publications.
Trial registration number NCT03139006; Pre-results.
- Computed tomography
- fractional flow reserve
- machine learning
- perfusion
- coronary artery disease
- cardiovascular imaging
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Footnotes
Contributors Design of the study: RWvH, II, PAdJ, MJW, MV and TL. Principal investigator: TL. Recruitment of patients: RWvH, MJMC, GEHL, MV and TL. Drafted study protocol and manuscript critically for important intellectual content: RWvH. Data collection, analysis and interpretation of the data: all authors. Revised study protocol and manuscript critically for important intellectual content: all authors. All authors have approved the final version of the manuscript.
Funding This work is funded by the Netherlands Organisation for Scientific Research (NWO) Domain Applied and Engineering Sciences (AES) under project number P15-26. The department of Radiology at University Medical Centre Utrecht receives research support from Philips Healthcare.
Disclaimer The authors are solely responsible for the design and conduct of the study, collection and analysis of the data, writing of the manuscript and its final contents.
Competing interests II received Research grants from Netherlands Organisation for Scientific Research (NWO)/ Foundation for Technological Sciences (number 12726) with industrial participation (Pie Medical Imaging, 3Mensio Medical Imaging). II and TL received research grants from The Netherlands Organisation for Health Research and Development (FSCAD, number 104003009); Research grants from Netherlands Organisation for Scientific Research (NWO) Domain Applied and Engineering Sciences (AES) (number P15-26) with industrial participation (Pie Medical Imaging, Philips Healthcare); Research grants Pie Medical Imaging. MJW and TL gave lectures for the Philips Healthcare Speakers Bureau.
Ethics approval The study protocol was reviewed and approved by the institutional review board of the University Medical Centre Utrecht (NL55917.041.16). In addition, the radiation safety committee approved this study.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.