title: Rationale and design of the ViCTORY (Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY) trial.
abstract: BACKGROUND
  Coronary CT angiography (CTA) has emerged as an effective noninvasive method for direct visualization of the coronary arteries, with high diagnostic performance compared with invasive coronary angiography (ICA). However, coronary CTA is prone to artifacts, including coronary motion, which may reduce its diagnostic performance. Intracycle motion compensation algorithms (MCAs) from a combination of software and hardware techniques now allow for correction of coronary motion, but the diagnostic performance of MCAs compared with traditional coronary CTA reconstruction methods remains unexplored.
  
  
  METHODS
  ViCTORY (Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY) is a prospective international multicenter trial of 218 patients which is designed to evaluate the performance of MCAs for the diagnosis of anatomically obstructive coronary artery disease (CAD) compared with an ICA reference standard, on a per-patient, per-vessel, and per-segment basis. Patients enrolled into ViCTORY will undergo investigational coronary CTA and clinically indicated ICA and will not receive heart rate-lowering medications before coronary CTA. Coronary CTA images will be reconstructed by conventional standard methods as well as by MCAs. Blinded core laboratory interpretation will be performed for coronary CTA and ICA in an intent-to-diagnose fashion.
  
  
  RESULTS
  The primary end point of ViCTORY is the per-patient diagnostic accuracy of MCAs for the diagnosis of anatomically obstructive CAD compared with ICA. Secondary end points will include other per-patient, per-vessel, and per-segment diagnostic performance characteristics, including accuracy, sensitivity, specificity, positive predictive value, and negative predictive value. Other key secondary end points will include diagnostic interpretability, image quality, the upper heart rate threshold of utility of MCAs, and the additive value of MCAs to traditionally reconstructed coronary CTA.
  
  
  CONCLUSIONS
  ViCTORY will determine whether MCAs improve the diagnosis of obstructive CAD in patients undergoing coronary CTA who are not receiving heart rate-lowering medications.
authors.affiliation: Department of Medicine and Imaging and Biomedical Sciences, Cedars-Sinai Heart Institute and Cedars-Sinai Medical Center, 8700 Beverly Boulevard, S Mark Taper Building Room 1253, Los Angeles, CA 90048, USA. james.min@cshs.org
authors.forename: James K
authors.initials: JK
authors.lastname: Min
authors.forename: Reza
authors.initials: R
authors.lastname: Arsanjani
authors.forename: Sachio
authors.initials: S
authors.lastname: Kurabayashi
authors.forename: Daniele
authors.initials: D
authors.lastname: Andreini
authors.forename: Gianluca
authors.initials: G
authors.lastname: Pontone
authors.forename: Byung-Wook
authors.initials: BW
authors.lastname: Choi
authors.forename: Hyuk-Jae
authors.initials: HJ
authors.lastname: Chang
authors.forename: Bin
authors.initials: B
authors.lastname: Lu
authors.forename: Jagat
authors.initials: J
authors.lastname: Narula
authors.forename: Afshin
authors.initials: A
authors.lastname: Karimi
authors.forename: Carl
authors.initials: C
authors.lastname: Roobottom
authors.forename: Millie
authors.initials: M
authors.lastname: Gomez
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Berman
authors.forename: Ricardo C
authors.initials: RC
authors.lastname: Cury
authors.forename: Todd
authors.initials: T
authors.lastname: Villines
authors.forename: Joon
authors.initials: J
authors.lastname: Kang
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
mesh_terms: D000465:Algorithms; D002986:Clinical Trials as Topic; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging*; D003627:Data Interpretation, Statistical; D006801:Humans; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D011857:Radiographic Image Interpretation, Computer-Assisted; D012107:Research Design; D012680:Sensitivity and Specificity; D012984:Software; D014057:Tomography, X-Ray Computed
keywords: Computed tomography; Coronary artery disease; Intracycle motion correction