title: Coronary CT angiography using 64 detector rows: methods and design of the multi-centre trial CORE-64.
abstract: Multislice computed tomography (MSCT) for the noninvasive detection of coronary artery stenoses is a promising candidate for widespread clinical application because of its non-invasive nature and high sensitivity and negative predictive value as found in several previous studies using 16 to 64 simultaneous detector rows. A multi-centre study of CT coronary angiography using 16 simultaneous detector rows has shown that 16-slice CT is limited by a high number of nondiagnostic cases and a high false-positive rate. A recent meta-analysis indicated a significant interaction between the size of the study sample and the diagnostic odds ratios suggestive of small study bias, highlighting the importance of evaluating MSCT using 64 simultaneous detector rows in a multi-centre approach with a larger sample size. In this manuscript we detail the objectives and methods of the prospective "CORE-64" trial ("Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors"). This multi-centre trial was unique in that it assessed the diagnostic performance of 64-slice CT coronary angiography in nine centres worldwide in comparison to conventional coronary angiography. In conclusion, the multi-centre, multi-institutional and multi-continental trial CORE-64 has great potential to ultimately assess the per-patient diagnostic performance of coronary CT angiography using 64 simultaneous detector rows.
authors.affiliation: Department of Medicine, Division of Cardiology, Johns Hopkins Hospital, Johns Hopkins University, Baltimore, MD, USA. jmmiller@jhmi.edu
authors.forename: Julie M
authors.initials: JM
authors.lastname: Miller
authors.forename: Marc
authors.initials: M
authors.lastname: Dewey
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Vavere
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Rochitte
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Niinuma
authors.forename: Armin
authors.initials: A
authors.lastname: Arbab-Zadeh
authors.forename: Narinder
authors.initials: N
authors.lastname: Paul
authors.forename: John
authors.initials: J
authors.lastname: Hoe
authors.forename: Albert
authors.initials: A
authors.lastname: de Roos
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Yoshioka
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Lemos
authors.forename: David E
authors.initials: DE
authors.lastname: Bush
authors.forename: Albert C
authors.initials: AC
authors.lastname: Lardo
authors.forename: John
authors.initials: J
authors.lastname: Texter
authors.forename: Jeffery
authors.initials: J
authors.lastname: Brinker
authors.forename: Christopher
authors.initials: C
authors.lastname: Cox
authors.forename: Melvin E
authors.initials: ME
authors.lastname: Clouse
authors.forename: João A C
authors.initials: JA
authors.lastname: Lima
mesh_terms: D002986:Clinical Trials as Topic; D003287:Contrast Media / Q000494:pharmacology; D017023:Coronary Angiography / Q000295:instrumentation* / Q000379:methods*; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000000981:diagnostic imaging; D003331:Coronary Vessels / Q000033:anatomy & histology; D004867:Equipment Design; D006801:Humans; D007373:Interinstitutional Relations; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results; D012107:Research Design; D018401:Sample Size; D014057:Tomography, X-Ray Computed / Q000295:instrumentation* / Q000379:methods*
chemical_list: D003287:Contrast Media