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).
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 (> or =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.
Marano
Riccardo
R
Department of Bioimaging and Radiological Sciences, Institute of Radiology, A. Gemelli Hospital - Catholic University, L.go A Gemelli 8, 00168 Rome, Italy. riccardo.marano@rm.unicatt.it
De Cobelli
Francesco
F
Floriani
Irene
I
Becker
Christoph
C
Herzog
Christopher
C
Centonze
Maurizio
M
Morana
Giovanni
G
Gualdi
Gian Franco
GF
Ligabue
Guido
G
Pontone
Gianluca
G
Catalano
Carlo
C
Chiappino
Dante
D
Midiri
Massimo
M
Simonetti
Giovanni
G
Marchisio
Filippo
F
Olivetti
Lucio
L
Fattori
Rossella
R
Bonomo
Lorenzo
L
Del Maschio
Alessandro
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000000981:diagnostic imaging*; D003952:Diagnostic Imaging / Q000379:methods; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D014057:Tomography, X-Ray Computed / Q000379:methods*