title: Rationale and design of the Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts study.
abstract: BACKGROUND
  Fractional flow reserve (FFR) measured by coronary computed tomography angiography (FFRCT) has been validated against invasive FFR. However, there are no data on how the use of FFRCT affects patient care and outcomes. The aim of this study is to compare standard practice guided by usual care testing to FFRCT-guided management in symptomatic subjects with suspected coronary artery disease (CAD).
  
  
  METHODS
  In this prospective nonrandomized trial, symptomatic patients with suspected CAD will be enrolled in 2 consecutive cohorts: a usual care-guided pathway (cohort 1) and an FFRCT-guided pathway (cohort 2). Each cohort is divided into 2 groups according to whether noninvasive or invasive diagnostic testing was planned before enrollment. In all subjects, the patient's clinical team will review all diagnostic test results and determine a treatment strategy. A total sample size of 580 subjects will be enrolled and followed up for 12 months.
  
  
  RESULTS
  The primary end point is the comparison of the percentage of patients with planned invasive testing who have a catheterization (invasive coronary angiography) within 90 days from initial assessment, which does not show a significant stenosis (defined as coronary artery stenosis >50% or invasive FFR ≤0.80). Secondary end points include the rate of invasive coronary angiography without obstructive CAD in those with planned noninvasive testing and, in all groups, noninferiority of resource use, quality of life, medical radiation exposure, and major adverse cardiac events up to 365 days of follow-up.
  
  
  CONCLUSIONS
  The study compares clinical and economic outcomes based on diagnostic evaluation using FFRCT with that based on standard diagnostic strategies.
authors.affiliation: Centro Cardiologico Monzino, IRCCS, Milan, Italy. Electronic address: gianluca.pontone@ccfm.it.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Pontone
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Manesh R
authors.initials: MR
authors.lastname: Patel
authors.affiliation: Stanford University School of Medicine, Stanford, CA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Hlatky
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Karen
authors.initials: K
authors.lastname: Chiswell
authors.affiliation: Centro Cardiologico Monzino, IRCCS, Milan, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Andreini
authors.affiliation: Aarhus University Hospital Skejby, Aarhus Denmark.
authors.forename: Bjarne Linde
authors.initials: BL
authors.lastname: Norgaard
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.affiliation: University Hospital Southampton NHS Trust, Southampton, United Kingdom.
authors.forename: Nick
authors.initials: N
authors.lastname: Curzen
authors.affiliation: Freeman Hospital, Newcastle upon Tyne, United Kingdom.
authors.forename: Ian
authors.initials: I
authors.lastname: Purcell
authors.affiliation: University Leipzig, Heart Center Leipzig, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Gutberlet
authors.affiliation: Hospices Civils de Lyon and CARMEN INSERM, Lyon, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Rioufol
authors.affiliation: Johannes Gutenberg University Hospital, Cardiology Department, Mainz, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Hink
authors.affiliation: LKH Graz West, Graz, Austria.
authors.forename: Herwig W
authors.initials: HW
authors.lastname: Schuchlenz
authors.affiliation: Department of Radiology, Innsbruck Medical University, Innsbruck, Austria.
authors.forename: Gudrun
authors.initials: G
authors.lastname: Feuchtner
authors.affiliation: CHU de la Cavale Blanche département de Cardiologie, Service Hémodynamique, Brest, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.affiliation: Cardiovascular Center Aalst, Aalst, Belgium.
authors.forename: Bernard
authors.initials: B
authors.lastname: de Bruyne
authors.affiliation: HeartFlow, Redwood City, CA.
authors.forename: Campbell
authors.initials: C
authors.lastname: Rogers
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
mesh_terms: D000368:Aged; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D053805:Fractional Flow Reserve, Myocardial / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014057:Tomography, X-Ray Computed