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      Clinical evaluation of magnetic resonance imaging in coronary heart disease: The CE-MARC study

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          Abstract

          Background

          Several investigations are currently available to establish the diagnosis of coronary heart disease (CHD). Of these, cardiovascular magnetic resonance (CMR) offers the greatest information from a single test, allowing the assessment of myocardial function, perfusion, viability and coronary artery anatomy. However, data from large scale studies that prospectively evaluate the diagnostic accuracy of multi-parametric CMR for the detection of CHD in unselected populations are lacking, and there are few data on the performance of CMR compared with current diagnostic tests, its prognostic value and cost-effectiveness.

          Methods/design

          This is a prospective diagnostic accuracy cohort study of 750 patients referred to a cardiologist with suspected CHD. Exercise tolerance testing (ETT) will be preformed if patients are physically able. Recruited patients will then undergo CMR and single photon emission tomography (SPECT) followed in all patients by invasive X-ray coronary angiography. The order of the CMR and SPECT tests will be randomised. The CMR study will comprise rest and adenosine stress perfusion, cine imaging, late gadolinium enhancement and whole-heart MR coronary angiography. SPECT will use a gated stress/rest protocol. The primary objective of the study is to determine the diagnostic accuracy of CMR in detecting significant coronary stenosis, as defined by X-ray coronary angiography. Secondary objectives include an assessment of the prognostic value of CMR imaging, a comparison of its diagnostic accuracy against SPECT and ETT, and an assessment of cost-effectiveness.

          Discussion

          The CE-MARC study is a prospective, diagnostic accuracy cohort study of 750 patients assessing the performance of a multi-parametric CMR study in detecting CHD using invasive X-ray coronary angiography as the reference standard and comparing it with ETT and SPECT.

          Trial Registration

          Current Controlled Trials ISRCTN77246133

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          Most cited references15

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          Risk of cancer from diagnostic X-rays: estimates for the UK and 14 other countries.

          Diagnostic X-rays are the largest man-made source of radiation exposure to the general population, contributing about 14% of the total annual exposure worldwide from all sources. Although diagnostic X-rays provide great benefits, that their use involves some small risk of developing cancer is generally accepted. Our aim was to estimate the extent of this risk on the basis of the annual number of diagnostic X-rays undertaken in the UK and in 14 other developed countries. We combined data on the frequency of diagnostic X-ray use, estimated radiation doses from X-rays to individual body organs, and risk models, based mainly on the Japanese atomic bomb survivors, with population-based cancer incidence rates and mortality rates for all causes of death, using life table methods. Our results indicate that in the UK about 0.6% of the cumulative risk of cancer to age 75 years could be attributable to diagnostic X-rays. This percentage is equivalent to about 700 cases of cancer per year. In 13 other developed countries, estimates of the attributable risk ranged from 0.6% to 1.8%, whereas in Japan, which had the highest estimated annual exposure frequency in the world, it was more than 3%. We provide detailed estimates of the cancer risk from diagnostic X-rays. The calculations involved a number of assumptions and so are inevitably subject to considerable uncertainty. The possibility that we have overestimated the risks cannot be ruled out, but that we have underestimated them substantially seems unlikely.
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            ACC/AHA 2002 guideline update for exercise testing: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines).

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              Sample size calculations in studies of test accuracy.

              Methods for determining sample size for studies of the accuracy of diagnostic tests are reviewed. Several accuracy indices are considered, including sensitivity and specificity, the full and partial area under the receiver operating characteristic curve, the sensitivity at a fixed false positive rate, and the likelihood ratio. Sample size formulae are presented for studies evaluating a single test and studies comparing the accuracy of tests. Four real examples illustrate the concepts involved in sample size determination. Lastly, various study design issues are discussed, such as sampling methods, choices in format for the test results, and the issue of replicated readings.
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                Author and article information

                Journal
                Trials
                Trials
                BioMed Central
                1745-6215
                2009
                29 July 2009
                : 10
                : 62
                Affiliations
                [1 ]Division of Cardiovascular and Neuronal Remodelling, Leeds Institute of Genetics, Health and Therapeutics, University of Leeds, G-Floor, Jubilee Wing, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK
                [2 ]Division of Medical Physics, University of Leeds, Leeds, LS2 9JT, UK
                [3 ]Clinical Trials Research Unit, University of Leeds, Clinical Trials Research House, 71-75 Clarendon Rd, Leeds, LS2 9PH, UK
                [4 ]Department of Nuclear Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK
                [5 ]Department of Medical Physics, Leeds Teaching Hospitals NHS Trust, Leeds, LS2 9JT, UK
                [6 ]Centre for Health Economics, University of York, Heslington, York, YO10 5DD, UK
                Article
                1745-6215-10-62
                10.1186/1745-6215-10-62
                3224948
                19640271
                2e4e2b97-03c5-4bfb-94c7-15a6426b8fc7
                Copyright ©2009 Greenwood 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
                : 28 April 2009
                : 29 July 2009
                Categories
                Study Protocol

                Medicine
                Medicine

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