Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial.

OBJECTIVES: More than 3.5 million invasive coronary angiographies (ICA) are performed in Europe annually. Approximately 2 million of these invasive procedures might be reduced by noninvasive tests because no coronary intervention is performed. Computed tomography (CT) is the most accurate noninvasive test for detection and exclusion of coronary artery disease (CAD). To investigate the comparative effectiveness of CT and ICA, we designed the European pragmatic multicentre DISCHARGE trial funded by the 7th Framework Programme of the European Union (EC-GA 603266). METHODS: In this trial, patients with a low-to-intermediate pretest probability (10-60 %) of suspected CAD and a clinical indication for ICA because of stable chest pain will be randomised in a 1-to-1 ratio to CT or ICA. CT and ICA findings guide subsequent management decisions by the local heart teams according to current evidence and European guidelines. RESULTS: Major adverse cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction and stroke as a composite endpoint will be the primary outcome measure. Secondary and other outcomes include cost-effectiveness, radiation exposure, health-related quality of life (HRQoL), socioeconomic status, lifestyle, adverse events related to CT/ICA, and gender differences. CONCLUSIONS: The DISCHARGE trial will assess the comparative effectiveness of CT and ICA. KEY POINTS: • Coronary artery disease (CAD) is a major cause of morbidity and mortality. • Invasive coronary angiography (ICA) is the reference standard for detection of CAD. • Noninvasive computed tomography angiography excludes CAD with high sensitivity. • CT may effectively reduce the approximately 2 million negative ICAs in Europe. • DISCHARGE addresses this hypothesis in patients with low-to-intermediate pretest probability for CAD.

Functional Analysis Outcomes and Comparison of Direct Observations and Informant Rating Scales in the Assessment of Severe Behavior Problems of Infants and Toddlers At-Risk for Developmental Delays.

Severe problem behaviors, like aggression, self-injury, and repetitive behaviors, in people with intellectual and developmental disabilities often appear during early development and may persist without early intervention. The frequencies of self-injurious behavior, aggression, tantrums, property destruction and stereotyped behavior among 17 infants and toddlers at risk for developmental delays and severe behavior problems were assessed using two methods: 1) direct observation of responses during 10 s partial interval recording during analogue functional analysis and 2) the Behavior Problem Inventory-01 (BPI-01; Rojahn et al, 2001), an informant rating scale. Analogue functional analysis results suggested that the most common function for problem behavior was automatic reinforcement, followed by negative reinforcement in the form of escape from demands. Agreement across the two types of measurement systems as to occurrence of the behaviors reported on the BPI-01 and direct observations during analogue functional analyses was greater than 75% across aggression, self-injury, and stereotyped behavior. Agreement at a more molecular level of the ranking of the most commonly occurring specific behaviors was considerably lower. Results are discussed in terms of future research on identifying conditions that set the occasion for high levels of agreement between indirect and direct measurement systems for severe behavior problems.

Validity and reliability of the Behavior Problems Inventory, the Aberrant Behavior Checklist, and the Repetitive Behavior Scale-Revised among infants and toddlers at risk for intellectual or developmental disabilities: a multi-method assessment approach.

Reliable and valid assessment of aberrant behaviors is essential in empirically verifying prevention and intervention for individuals with intellectual or developmental disabilities (IDD). Few instruments exist which assess behavior problems in infants. The current longitudinal study examined the performance of three behavior-rating scales for individuals with IDD that have been proven psychometrically sound in older populations: the Aberrant Behavior Checklist (ABC), the Behavior Problems Inventory (BPI-01), and the Repetitive Behavior Scale - Revised (RBS-R). Data were analyzed for 180 between six and 36 months old children at risk for IDD. Internal consistency (Cronbach's α) across the subscales of the three instruments was variable. Test-retest reliability of the three BPI-01 subscales ranged from .68 to .77 for frequency ratings and from .65 to .80 for severity ratings (intraclass correlation coefficients). Using a multitrait-multimethod matrix approach high levels of convergent and discriminant validity across the three instruments was found. As anticipated, there was considerable overlap in the information produced by the three instruments; however, each behavior-rating instrument also contributed unique information. Our findings support using all three scales in conjunction if possible.

Semi-automatic assessment of global left ventricular function and left ventricular parameters with dual-source computed tomography: comparison with invasive angiography.

This study assesses the global left ventricular function and volumes using dual-source computed tomography (DSCT) with improved temporal resolution (83 ms) by use of a semi-automatic software tool in comparison to invasive angiography (IVA). One hundred patients scheduled for invasive coronary angiography because of suspected or known coronary artery disease (80 men; 20 women, mean age 62 +/- 10 years) were additionally examined by DSCT. Global left ventricular function (LVF), left ventricular end-diastolic volume (LVEDV), end-systolic volume (LVESV), and stroke volume (SV) were calculated by the use of semi-automatic post-processing software and results compared with those of IVA. Bland-Altman analysis revealed a good concordance between DSCT and IVA in terms of LVF: Pearson's r 0.78, confidence interval [CI] 0.68-0.86, P < 0.0001, bias 7.1% +/- 9.1%. The same was true for LVESV (Pearson's r 0.78, CI 0.67-0.85, P < 0.0001, bias 15.0 +/- 21.0 ml), whereas the agreement for LVEDV and SV was only moderate (LVEDV: Pearson's r 0.59, CI 0.43-0.72, P < 0.0001, bias 13.0 +/- 18.1 ml; SV: Pearson's r 0.47, CI 0.28-0.62, P < 0.0001, bias -1.4 +/- 28.4 ml). Semi-automatic evaluation of left ventricular parameters with DSCT revealed good correlation for LVF and LVESV, whereas LVEDV and SV showed only a moderate correlation. Moreover, LVF is systematically underestimated by DSCT.

Dual-source CT with improved temporal resolution in assessment of left ventricular function: a pilot study.

OBJECTIVE: Functional analysis using MDCT has been limited by insufficient temporal resolution. The aim of this study was to assess the performance of a dual-source CT system with improved temporal resolution in the determination of both volume- or time-dependent functional parameters and regional wall motion in comparison with cine MRI. SUBJECTS AND METHODS: Twenty patients (15 of whom had previous myocardial infarction) were prospectively examined using dual-source CT. MRI was used as the standard of reference. Using the Simpson's method, ventricular volumes were determined for the whole of the cardiac cycle and results compared using Parson's correlation and Bland-Altman analysis. Regional wall motion was assessed on cine images and compared using weighted kappa statistics. RESULTS: Dual-source CT revealed a strong correlation with cine MRI regarding the quantification of end-diastolic volume (r = 0.98), end-systolic volume (r = 0.99), stroke volume (r = 0.96), and ejection fraction (r = 0.95). Good correlation was obtained for peak ejection rate (r = 0.79) and peak filling rate (r = 0.84), whereas agreement proved only moderate for time-to-peak ejection rate (r = 0.68) or time-to-peak filling rate from end-systole (r = 0.64). The mean difference for ejection fraction was negligible (bias, 0.72%). Good agreement between both techniques was likewise found for regional wall motion (kappa = 0.88). CONCLUSION: With the improvement of temporal resolution between 42 and 83 milliseconds, dual-source CT not only enables accurate assessment of global functional parameters, but it also allows for quantification of time-dependent variables and reliable evaluation of regional wall motion.

Assessment of myocardial viability in a reperfused porcine model: evaluation of different MSCT contrast protocols in acute and subacute infarct stages in comparison with MRI.

OBJECTIVE: To assess myocardial viability in acute and subacute infarcts using different multislice spiral computed tomography contrast protocols with magnetic resonance imaging (MRI) correlation. METHODS: Seven pigs were studied with 64-multislice spiral computed tomography and MRI (1.5 T) at a median of 1 and 21 days after temporary occlusion of the second diagonal branch. Computed tomography was performed at 3, 5, 10, and 15 minutes after injection of contrast medium. Contrast agent was applied either as a bolus (protocol 1; n = 7 for the first; n = 5 for the second scan) or as a bolus plus 30 mL of subsequent 0.1 mL/s low-flow (protocol 2; n = 7 for the first; n = 6 for the second scan). Finally, histological sections were obtained. Volumes of infarcted myocardium were assessed as the percentage of the left ventricle. Computed tomography attenuation values were obtained, and image quality was assessed. RESULTS: When compared with protocol 1, protocol 2 provided greater Hounsfield unit attenuation difference between viable and nonviable myocardium at 5, 10, and 15 minutes (P = 0.19; 0.003; 0.0006) and an additional significant contrast between nonviable myocardium and ventricular blood at 3 and 5 minutes (P < 0.001). Image quality was rated significantly higher with the use of protocol 2 at 5, 10, and 15 minutes (P < or = 0.027) and for all time points use of protocol 2 resulted in improved correlation of acute and subacute infarct size with MRI. CONCLUSIONS: Good correlation of infarct zones with MRI was achieved for both acute and subacute infarcts. With the use of a bolus/low-flow protocol, image quality was substantially improved by means of a higher tissue contrast.

Assessment of left ventricular myocardial function using 16-slice multidetector-row computed tomography: comparison with magnetic resonance imaging and echocardiography.

OBJECTIVE: To assess functional parameters using multidetector-row computed tomography (MDCT) and echocardiography and to compare the results with magnetic resonance imaging (MRI). MATERIALS AND METHODS: End-diastolic-volume (EDV), end-systolic-volume (ESV), stroke-volume (SV), ejection-fraction (EF), and myocardial mass (MM) were calculated based on CT data sets from 52 patients. Echocardiography was performed in 24 of the 52 patients. The results from MDCT and echocardiography were compared with MRI. RESULTS: A strong correlation between MDCT and MRI (r=0.66-0.90) was found for all parameters. Echocardiography revealed a low or moderate correlation (0.05-0.59). Compared to MRI the average differences with MDCT were for EDV 15.1 ml, ESV 10.6 ml, SV 4.5 ml, EF 1.8%, and MM 8.2 g, for EDV determined by echocardiography 36.2 ml, ESV 6.8 ml, and EF 13.9%. Bland-Altman analysis revealed acceptable limits of agreement between MRI and MDCT. CONCLUSIONS: MDCT enables reliable quantification of left ventricular function. Echocardiography was found to have only a moderate agreement of functional parameters with MRI.

ECG-gated 16-MDCT of the coronary arteries: assessment of image quality and accuracy in detecting stenoses.

OBJECTIVE: The aim of this study was to investigate image quality and diagnostic accuracy in detecting coronary artery lesions using a 16-MDCT scanner. MATERIALS AND METHODS: Thirty-seven patients (28 men, nine women) underwent unenhanced helical CT and MDCT angiography of the coronary arteries. After patients received oral beta-blocker medication, CT scans were obtained during a single breath-hold with a 16-MDCT scanner using ECG-gating (0.75-mm collimation, 2.8-mm table feed/rotation, 0.42-sec rotation time). The image quality was assessed in terms of artifacts and segment visibility by two reviewers. Stenosis severity was compared with the results of conventional invasive coronary angiography. RESULTS: The data evaluation of the image quality was based on a total of 488 segments, of which 380 segments were considered to have diagnostic image quality. One hundred eight segments (22.1%) could not be sufficiently evaluated because of severe calcifications (35 segments) and motion artifacts (73 segments). The mean calcium score (Agatston score equivalent [ASE]) was 524.3 +/- 807.6. Twenty-eight (75.7%) of the 37 patients had an ASE of less than 1,000 (mean ASE, 90.8 +/- 152.3 [SD]), and nine (24.3%) patients had an ASE of 1,000 or greater (mean ASE, 1,761.0 +/- 637.6). For detecting lesions 50% or greater (without any exclusion criteria), the overall sensitivity, specificity, positive predictive value, and negative predictive value were 59%, 87%, 61%, and 87%, respectively. When limiting the number of patients to those with a calcium score of less than 1,000 ASE, the threshold-corrected sensitivity for lesions 50% or greater was 93%; specificity, 94%; positive predictive value, 68%; and negative predictive value, 99%. CONCLUSION: In patients with no or moderate coronary calcification, MDCT of coronary arteries using 16-MDCT technology allows the reliable detection of coronary artery stenoses with high diagnostic accuracy. Obtaining an initial unenhanced scan was found to be mandatory to avoid performing useless examinations in patients with severe calcifications.

Kinetic assessment of the effects of task difficulty, microencephaly, and a response manipulandum alteration on the rate of fixed-ratio discrimination acquisition.

Fixed-ratio discrimination (FRD) training session-accuracy curves were constructed using first-order, nonlinear regression and probit analyses to determine maximal (asymptotic) accuracy and the number of sessions required to reach half-maximal accuracy. Increased FRD difficulty (reductions in the differences between the 2 fixed-ratio values to be discriminated) and a training parameter change each increased the number of sessions required to reach half-maximal accuracy and decreased maximal FRD accuracy (i.e., session-accuracy curves were shifted down and to the right) regardless of analysis procedure. These findings indicate that the above manipulations induced mixed competitive-noncompetitive inhibition of the rate of FRD learning. Microencephalic rats were more sensitive to increases in FRD difficulty, whereas control rats were more sensitive to the training parameter change.