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      Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease

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          Abstract

          Background

          In patients with stable coronary artery disease (CAD), decisions regarding revascularisation are primarily driven by the severity and extent of coronary luminal stenoses as determined by invasive coronary angiography. More recently, revascularisation decisions based on invasive fractional flow reserve (FFR) have shown improved event free survival. Cardiovascular magnetic resonance (CMR) perfusion imaging has been shown to be non-inferior to nuclear perfusion imaging in a multi-centre setting and superior in a single centre trial. In addition, it is similar to invasively determined FFR and therefore has the potential to become the non-invasive test of choice to determine need for revascularisation.

          Trial design

          The MR-INFORM study is a prospective, multi-centre, randomised controlled non-inferiority, outcome trial. The objective is to compare the efficacy of two investigative strategies for the management of patients with suspected CAD. Patients presenting with stable angina are randomised into two groups: 1) The FFR-INFORMED group has subsequent management decisions guided by coronary angiography and fractional flow reserve measurements. 2) The MR-INFORMED group has decisions guided by stress perfusion CMR. The primary end-point will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation) at one year. Clinical trials.gov identifier NCT01236807.

          Conclusion

          MR INFORM will assess whether an initial strategy of CMR perfusion is non-inferior to invasive angiography supplemented by FFR measurements to guide the management of patients with stable coronary artery disease. Non-inferiority of CMR perfusion imaging to the current invasive reference standard (FFR) would establish CMR perfusion imaging as an attractive non-invasive alternative to current diagnostic pathways.

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          Most cited references10

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          Universal definition of myocardial infarction.

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            JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice.

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              Diagnostic performance of stress cardiac magnetic resonance imaging in the detection of coronary artery disease: a meta-analysis.

              The purpose of our study was to conduct an evidence-based evaluation of stress cardiac magnetic resonance imaging (MRI) in the diagnosis of coronary artery disease (CAD). Stress cardiac MRI has recently emerged as a noninvasive method in the detection of CAD, with 2 main techniques in use: 1) perfusion imaging; and 2) stress-induced wall motion abnormalities imaging. We examined studies from January 1990 to January 2007 using MEDLINE and EMBASE. A study was included if it: 1) used stress MRI as a diagnostic test for CAD (> or =50% diameter stenosis); and 2) used catheter X-ray angiography as the reference standard. Thirty-seven studies (2,191 patients) met the inclusion criteria, with 14 datasets (754 patients) using stress-induced wall motion abnormalities imaging and 24 datasets (1,516 patients) using perfusion imaging. Stress-induced wall motion abnormalities imaging demonstrated a sensitivity of 0.83 (95% confidence interval [CI] 0.79 to 0.88) and specificity of 0.86 (95% CI 0.81 to 0.91) on a patient level (disease prevalence = 70.5%). Perfusion imaging demonstrated a sensitivity of 0.91 (95% CI 0.88 to 0.94) and specificity of 0.81 (95% CI 0.77 to 0.85) on a patient level (disease prevalence = 57.4%). In studies with high disease prevalence, stress cardiac MRI, using either technique, demonstrates overall good sensitivity and specificity for the diagnosis of CAD. However, limited data are available regarding use of either technique in populations with low disease prevalence.
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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
                19 September 2012
                : 14
                : 1
                : 65
                Affiliations
                [1 ]King’s College London, British Heart Foundation (BHF) Centre of Research Excellence, National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Trust Foundation, Joint Imaging and Cardiovascular Divisions, Kings Health Partners, 4th Floor Lambeth Wing, St. Thomas' Hospital, London, SE1 7EH, UK
                [2 ]Multidisciplinary Cardiovascular Research Centre & Leeds Institute of Genetics, Health and Therapeutics, University of Leeds, Leeds, United Kingdom
                [3 ]NIHR Leicester Cardiovascular Biomedical Research Unit, Leicester, UK
                [4 ]The London Chest Hospital, London, UK
                [5 ]Department of Cardiology and Pneumology and Heart Research Center, Georg-August-University, Göttingen, Germany
                Article
                1532-429X-14-65
                10.1186/1532-429X-14-65
                3533866
                22992411
                13d57bef-2985-4335-bdf1-ec175f46551a
                Copyright ©2012 Hussain 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
                : 30 March 2012
                : 9 August 2012
                Categories
                Study Protocol

                Cardiovascular Medicine
                perfusion,fractional flow reserve,stable angina,cardiovascular magnetic resonance,myocardial ischaemia

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