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      Superior diagnostic performance of perfusion-cardiovascular magnetic resonance versus SPECT to detect coronary artery disease: The secondary endpoints of the multicenter multivendor MR-IMPACT II (Magnetic Resonance Imaging for Myocardial Perfusion Assessment in Coronary Artery Disease Trial)

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          Abstract

          Background

          Perfusion-cardiovascular magnetic resonance (CMR) is generally accepted as an alternative to SPECT to assess myocardial ischemia non-invasively. However its performance vs gated-SPECT and in sub-populations is not fully established. The goal was to compare in a multicenter setting the diagnostic performance of perfusion-CMR and gated-SPECT for the detection of CAD in various populations using conventional x-ray coronary angiography (CXA) as the standard of reference.

          Methods

          In 33 centers (in US and Europe) 533 patients, eligible for CXA or SPECT, were enrolled in this multivendor trial. SPECT and CXA were performed within 4 weeks before or after CMR in all patients. Prevalence of CAD in the sample was 49% and 515 patients received MR contrast medium. Drop-out rates for CMR and SPECT were 5.6% and 3.7%, respectively (ns). The study was powered for the primary endpoint of non-inferiority of CMR vs SPECT for both, sensitivity and specificity for the detection of CAD (using a single-threshold reading), the results for the primary endpoint were reported elsewhere. In this article secondary endpoints are presented, i.e. the diagnostic performance of CMR versus SPECT in subpopulations such as multi-vessel disease (MVD), in men, in women, and in patients without prior myocardial infarction (MI). For diagnostic performance assessment the area under the receiver-operator-characteristics-curve (AUC) was calculated. Readers were blinded versus clinical data, CXA, and imaging results.

          Results

          The diagnostic performance (= area under ROC = AUC) of CMR was superior to SPECT (p = 0.0004, n = 425) and to gated-SPECT (p = 0.018, n = 253). CMR performed better than SPECT in MVD (p = 0.003 vs all SPECT, p = 0.04 vs gated-SPECT), in men (p = 0.004, n = 313) and in women (p = 0.03, n = 112) as well as in the non-infarct patients (p = 0.005, n = 186 in 1–3 vessel disease and p = 0.015, n = 140 in MVD).

          Conclusion

          In this large multicenter, multivendor study the diagnostic performance of perfusion-CMR to detect CAD was superior to perfusion SPECT in the entire population and in sub-groups. Perfusion-CMR can be recommended as an alternative for SPECT imaging.

          Trial registration

          ClinicalTrials.gov, Identifier: NCT00977093

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          Most cited references20

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          The meaning and use of the area under a receiver operating characteristic (ROC) curve.

          A representation and interpretation of the area under a receiver operating characteristic (ROC) curve obtained by the "rating" method, or by mathematical predictions based on patient characteristics, is presented. It is shown that in such a setting the area represents the probability that a randomly chosen diseased subject is (correctly) rated or ranked with greater suspicion than a randomly chosen non-diseased subject. Moreover, this probability of a correct ranking is the same quantity that is estimated by the already well-studied nonparametric Wilcoxon statistic. These two relationships are exploited to (a) provide rapid closed-form expressions for the approximate magnitude of the sampling variability, i.e., standard error that one uses to accompany the area under a smoothed ROC curve, (b) guide in determining the size of the sample required to provide a sufficiently reliable estimate of this area, and (c) determine how large sample sizes should be to ensure that one can statistically detect differences in the accuracy of diagnostic techniques.
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            Measuring the accuracy of diagnostic systems.

            J Swets (1988)
            Diagnostic systems of several kinds are used to distinguish between two classes of events, essentially "signals" and "noise". For them, analysis in terms of the "relative operating characteristic" of signal detection theory provides a precise and valid measure of diagnostic accuracy. It is the only measure available that is uninfluenced by decision biases and prior probabilities, and it places the performances of diverse systems on a common, easily interpreted scale. Representative values of this measure are reported here for systems in medical imaging, materials testing, weather forecasting, information retrieval, polygraph lie detection, and aptitude testing. Though the measure itself is sound, the values obtained from tests of diagnostic systems often require qualification because the test data on which they are based are of unsure quality. A common set of problems in testing is faced in all fields. How well these problems are handled, or can be handled in a given field, determines the degree of confidence that can be placed in a measured value of accuracy. Some fields fare much better than others.
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              Estimating risk of cancer associated with radiation exposure from 64-slice computed tomography coronary angiography.

              Computed tomography coronary angiography (CTCA) has become a common diagnostic test, yet there are little data on its associated cancer risk. The recent Biological Effects of Ionizing Radiation (BEIR) VII Phase 2 report provides a framework for estimating lifetime attributable risk (LAR) of cancer incidence associated with radiation exposure from a CTCA study, using the most current data available on health effects of radiation. To determine the LAR of cancer incidence associated with radiation exposure from a 64-slice CTCA study and to evaluate the influence of age, sex, and scan protocol on cancer risk. Organ doses from 64-slice CTCA to standardized phantom (computational model) male and female patients were estimated using Monte Carlo simulation methods, using standard spiral CT protocols. Age- and sex-specific LARs of individual cancers were estimated using the approach of BEIR VII and summed to obtain whole-body LARs. Whole-body and organ LARs of cancer incidence. Organ doses ranged from 42 to 91 mSv for the lungs and 50 to 80 mSv for the female breast. Lifetime cancer risk estimates for standard cardiac scans varied from 1 in 143 for a 20-year-old woman to 1 in 3261 for an 80-year-old man. Use of simulated electrocardiographically controlled tube current modulation (ECTCM) decreased these risk estimates to 1 in 219 and 1 in 5017, respectively. Estimated cancer risks using ECTCM for a 60-year-old woman and a 60-year-old man were 1 in 715 and 1 in 1911, respectively. A combined scan of the heart and aorta had higher LARs, up to 1 in 114 for a 20-year-old woman. The highest organ LARs were for lung cancer and, in younger women, breast cancer. These estimates derived from our simulation models suggest that use of 64-slice CTCA is associated with a nonnegligible LAR of cancer. This risk varies markedly and is considerably greater for women, younger patients, and for combined cardiac and aortic scans.
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                Author and article information

                Journal
                J Cardiovasc Magn Reson
                J Cardiovasc Magn Reson
                Journal of Cardiovascular Magnetic Resonance
                BioMed Central
                1097-6647
                1532-429X
                2012
                2 September 2012
                : 14
                : 1
                : 61
                Affiliations
                [1 ]Cardiology, University Hospital Lausanne, Rue de Bugnon 46, CH-1011, Lausanne, Switzerland
                [2 ]University Hospital Wuerzburg, Wuerzburg, Germany
                [3 ]University of Florida Health Science Center, Gainesville/Jacksonville, USA
                [4 ]Franz-Volhard Clinic-Humboldt University, Berlin, Germany
                [5 ]Landshut Hospital, Landshut, Germany
                [6 ]Semmelweis University Hospital, Budapest, Hungary
                [7 ]LMU Munich, Grosshadern, Germany
                [8 ]current affiliation - University Medical Center Mannheim, Mannheim, Germany
                [9 ]University Hospital Regensburg, Regensburg, Germany
                [10 ]St. Gertrauden Hospital Berlin, Berlin, Germany
                [11 ]Uppsala University Hospital, Uppsala, Sweden
                [12 ]Kerckhoff Clinics Bad Nauheim, Nauheim, Germany
                [13 ]Current affiliation - Sana Kliniken Duesseldorf, Duesseldorf, Germany
                [14 ]GE Healthcare Buchler GmbH & Co.KG, Munich, Germany
                [15 ]Medical University of Science, Pecs, Hungary
                Article
                1532-429X-14-61
                10.1186/1532-429X-14-61
                3443449
                22938651
                739ef73f-1dfc-465d-979d-e5da208e0155
                Copyright ©2012 Schwitter et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 25 May 2012
                : 9 August 2012
                Categories
                Research

                Cardiovascular Medicine
                cardiovascular magnetic resonance,scintigraphy,perfusion,ischemia,coronary disease

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