Italian multicenter, prospective study to evaluate the negative predictive value of 16- and 64-slice MDCT imaging in patients scheduled for coronary angiography (NIMISCAD-Non Invasive Multicenter Italian Study for Coronary Artery Disease) |
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Authors: | Riccardo Marano Francesco De Cobelli Irene Floriani Christoph Becker Christopher Herzog Maurizio Centonze Giovanni Morana Gian Franco Gualdi Guido Ligabue Gianluca Pontone Carlo Catalano Dante Chiappino Massimo Midiri Giovanni Simonetti Filippo Marchisio Lucio Olivetti Rossella Fattori Lorenzo Bonomo Alessandro Del Maschio |
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Affiliation: | 1. Department of Bioimaging and Radiological Sciences, Institute of Radiology, “A. Gemelli” Hospital - Catholic University, L.go A Gemelli 8, 00168, Rome, Italy 2. S. Raffaele Scientific Institute, Vita-Salute University, Milan, Italy 3. Mario Negri Institute, Milan, Italy 4. Ludwig-Maximilians University, Munich, Germany 5. J. W. Goethe University, Frankfurt, Germany 6. S.Chiara Hospital, Trento, Italy 7. Cà Foncello Hospital, Treviso, Italy 8. DEA Umberto I Hospital, La Sapienza University, Rome, Italy 9. University of Modena and Reggio Emilia, Modena, Italy 10. Centro Cardiologico Monzino, Milan, Italy 11. Umberto I Hospital, La Sapienza University, Rome, Italy 12. G. Pasquinucci Hospital, Massa, Italy 13. DIBIMEL, University of Palermo, Palermo, Italy 14. Tor Vergata University, Rome, Italy 15. University of Turin, Turin, Italy 16. Istituti Ospitalieri of Cremona, Cremona, Italy 17. S. Orsola University Hospital, Bologna, Italy 18. A. Gemelli Hospital, Catholic University, Rome, Italy 19. S. Raffaele Scientific Institute, Vita-Salute University, Milan, Italy
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Abstract: | This was a prospective, multicenter study designed to evaluate the utility of MDCT in the diagnosis of coronary artery disease (CAD) in patients scheduled for elective coronary angiography (CA) using different MDCT systems from different manufacturers. Twenty national sites prospectively enrolled 367 patients between July 2004 and June 2006. Computed tomography (CT) was performed using a standardized/optimized scan protocol for each type of MDCT system (≥16 slices) and compared with quantitative CA performed within 2 weeks of MDCT. A total of 284 patients (81%) were studied by 16-slice MDCT systems, while 66 patients (19%) by 64-slice MDCT scanners. The primary analysis was on-site/off-site evaluation of the negative predictive value (NPV) on a per-patient basis. Secondary analyses included on-site evaluation on a per-artery and per-segment basis. On-site evaluation included 327 patients (CAD prevalence 58%). NPV, positive predictive value (PPV), sensitivity, specificity, and diagnostic accuracy (DA) were 0.91 (95% CI 0.85–0.95), 0.91 (95% CI 0.86–0.95), 0.94 (95% CI 0.89–0.97), 0.88 (95% CI 0.81–0.93), and 0.91 (95% CI 0.88–0.94), respectively. Off-site analysis included 295 patients (CAD prevalence 56%). NPV, PPV, sensitivity, specificity, and DA were 0.73 (95% CI 0.65–0.79), 0.93 (95% CI 0.87–0.97), 0.73 (95% CI 0.65–0.79), 0.93 (95% CI 0.87–0.97), and 0.82 (95% CI 0.77–0.86), respectively. The results of this study demonstrate the utility of MDCT in excluding significant CAD even when conducted by centers with varying degrees of expertise and using different MDCT machines. |
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Keywords: | Multidetector CT Coronary artery disease Cardiac CT |
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