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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)
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
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
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.
Keywords:Multidetector CT  Coronary artery disease  Cardiac CT
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