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      The global cardiovascular magnetic resonance registry (GCMR) of the society for cardiovascular magnetic resonance (SCMR): its goals, rationale, data infrastructure, and current developments

      research-article
      The Global Cardiovascular Magnetic Resonance Registry (GCMR) Investigators, 1 , 2 , , 3 , 4 , 5 , 6 , , , 7 , 1 , 8 , , , 9 , 10 , 11 , , , 5 , 12 , 13 , 9 , 14 , 15 , 16 , 17 , 17 , 18 , 19 , 19 , 20 , 21
      Journal of Cardiovascular Magnetic Resonance
      BioMed Central
      Registry, Cardiovascular magnetic resonance, Imaging, Patient management, Therapeutic implications

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          Abstract

          Background

          With multifaceted imaging capabilities, cardiovascular magnetic resonance (CMR) is playing a progressively increasing role in the management of various cardiac conditions. A global registry that harmonizes data from international centers, with participation policies that aim to be open and inclusive of all CMR programs, can support future evidence-based growth in CMR.

          Methods

          The Global CMR Registry (GCMR) was established in 2013 under the auspices of the Society for Cardiovascular Magnetic Resonance (SCMR). The GCMR team has developed a web-based data infrastructure, data use policy and participation agreement, data-harmonizing methods, and site-training tools based on results from an international survey of CMR programs.

          Results

          At present, 17 CMR programs have established a legal agreement to participate in GCMR, amongst them 10 have contributed CMR data, totaling 62,456 studies. There is currently a predominance of CMR centers with more than 10 years of experience (65%), and the majority are located in the United States (63%). The most common clinical indications for CMR have included assessment of cardiomyopathy (21%), myocardial viability (16%), stress CMR perfusion for chest pain syndromes (16%), and evaluation of etiology of arrhythmias or planning of electrophysiological studies (15%) with assessment of cardiomyopathy representing the most rapidly growing indication in the past decade. Most CMR studies involved the use of gadolinium-based contrast media (95%).

          Conclusions

          We present the goals, mission and vision, infrastructure, preliminary results, and challenges of the GCMR.

          Trial registration

          Identification number on ClinicalTrials.gov: NCT02806193. Registered 17 June 2016.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12968-016-0321-7) contains supplementary material, which is available to authorized users.

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          Most cited references5

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          European cardiovascular magnetic resonance (EuroCMR) registry – multi national results from 57 centers in 15 countries

          Abstract Background The EuroCMR registry sought to evaluate indications, image quality, safety and impact on patient management of clinical routine CMR in a multi-national European setting. Furthermore, interim analysis of the specific protocols should underscore the prognostic potential of CMR. Methods Multi-center registry with consecutive enrolment of patients in 57 centers in 15 countries. More than 27000 consecutive patients were enrolled. Results The most important indications were risk stratification in suspected CAD/Ischemia (34.2%), workup of myocarditis/cardiomyopathies (32.2%), as well as assessment of viability (14.6%). Image quality was diagnostic in more than 98% of cases. Severe complications occurred in 0.026%, always associated with stress testing. No patient died during or due to CMR. In 61.8% CMR findings impacted on patient management. Importantly, in nearly 8.7% the final diagnosis based on CMR was different to the diagnosis before CMR, leading to a complete change in management. Interim analysis of suspected CAD and risk stratification in HCM specific protocols revealed a low rate of adverse events for suspected CAD patients with normal stress CMR (1.0% per year), and for HCM patients without LGE (2.7% per year). Conclusion The most important indications in Europe are risk stratification in suspected CAD/Ischemia, work-up of myocarditis and cardiomyopathies, as well as assessment of viability. CMR imaging is a safe procedure, has diagnostic image quality in more than 98% of cases, and its results have strong impact on patient management. Interim analyses of the specific protocols underscore the prognostic value of clinical routine CMR in CAD and HCM. Condensed abstract The EuroCMR registry sought to evaluate indications, image quality, safety and impact on patient management of clinical routine CMR in a multi-national European setting in a large number of cases (n > 27000). Based on our data CMR is frequently performed in European daily clinical routine. The most important indications in Europe are risk stratification in suspected CAD/Ischemia, work-up of myocarditis and cardiomyopathies, as well as assessment of viability. CMR imaging is a safe procedure, has diagnostic image quality in more than 98% of cases, and its results have strong impact on patient management. Interim analyses of the specific protocols underscore the prognostic value of clinical routine CMR in CAD and HCM.
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            2015 Update on Acute Adverse Reactions to Gadolinium based Contrast Agents in Cardiovascular MR. Large Multi-National and Multi-Ethnical Population Experience With 37788 Patients From the EuroCMR Registry

            Objectives Specifically we aim to demonstrate that the results of our earlier safety data hold true in this much larger multi-national and multi-ethnical population. Background We sought to re-evaluate the frequency, manifestations, and severity of acute adverse reactions associated with administration of several gadolinium- based contrast agents during routine CMR on a European level. Methods Multi-centre, multi-national, and multi-ethnical registry with consecutive enrolment of patients in 57 European centres. Results During the current observation 37788 doses of Gadolinium based contrast agent were administered to 37788 patients. The mean dose was 24.7 ml (range 5–80 ml), which is equivalent to 0.123 mmol/kg (range 0.01 - 0.3 mmol/kg). Forty-five acute adverse reactions due to contrast administration occurred (0.12 %). Most reactions were classified as mild (43 of 45) according to the American College of Radiology definition. The most frequent complaints following contrast administration were rashes and hives (15 of 45), followed by nausea (10 of 45) and flushes (10 of 45). The event rate ranged from 0.05 % (linear non-ionic agent gadodiamide) to 0.42 % (linear ionic agent gadobenate dimeglumine). Interestingly, we also found different event rates between the three main indications for CMR ranging from 0.05 % (risk stratification in suspected CAD) to 0.22 % (viability in known CAD). Conclusions The current data indicate that the results of the earlier safety data hold true in this much larger multi-national and multi-ethnical population. Thus, the “off-label” use of Gadolinium based contrast in cardiovascular MR should be regarded as safe concerning the frequency, manifestation and severity of acute events.
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              Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry.

              The purpose of this study was to assess the frequency, manifestation, and severity of acute adverse reactions associated with administration of several gadolinium-based contrast agents to patients who underwent cardiac magnetic resonance (CMR) imaging in the EuroCMR (European Cardiovascular Magnetic Resonance) Registry multinational and multicenter setting. The frequency, manifestations, and severity of acute adverse reactions associated with gadolinium-based contrast agents in the specific setting of cardiovascular magnetic resonance have not been systematically evaluated yet. This is a multicenter and multinational registry with consecutive enrollment of patients in 45 European centers. During the current observation, 17,767 doses of gadolinium-based contrast agent were administered to 17,767 patients. The mean dose was 25.6 ml (range 5 to 80 ml), which is equivalent to 0.128 mmol/kg (range 0.012 to 0.3 mmol/kg). Thirty acute adverse reactions due to contrast administration occurred (0.17%). All reactions were classified as mild according to the American College of Radiology definition. The most frequent complaints following contrast administration were rashes and hives (9 of 30), followed by nausea (7 of 30), and anxiety (6 of 30). The event rate ranged from 0.06% (linear nonionic agent gadodiamide) to 0.47% (linear ionic agent gadobenate dimeglumine). Interestingly, we also found different event rates between the three main indications for CMR imaging, ranging from 0.1% (risk stratification in suspected coronary artery disease) to 0.42% (viability in known coronary artery disease). The incidence of acute adverse reactions after administration of gadolinium-based contrast in the "off-label" setting of CMR in our population was not different from the incidence in the U.S. Food and Drug Administration-approved general radiology setting. Thus, the off-label use of gadolinium-based contrast in CMR should be regarded as safe concerning the frequency, manifestation, and severity of acute events. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                (857) 307-1060 , rykwong@partners.org
                s.e.petersen@qmul.ac.uk
                jeanette.schulz-menger@charite.de
                araia@nhlbi.nih.gov
                sbingham@cut.net
                chenyucheng123@hotmail.com
                ylchoi@partners.org
                RCury@baptisthealth.net
                vanessa.ferreira@cardiov.ox.ac.uk
                flamms@ccf.org
                Kevin.steel@acishealth.org
                ingkanip@nhlbi.nih.gov
                edward.martin@oklahomaheart.com
                xraymd@gmail.com
                stefan.neubauer@cardiov.ox.ac.uk
                Subha.Raman@osumc.edu
                schelberteb@upmc.edu
                uvaleti@gmail.com
                Jane.Cao@chsli.org
                Nathaniel.Reichek@chsli.org
                a.young@auckland.ac.nz
                lfexon@partners.org
                mpivovarov@partners.org
                ferrariv@mail.med.upenn.edu
                Orlando.Simonetti@osumc.edu
                Journal
                J Cardiovasc Magn Reson
                J Cardiovasc Magn Reson
                Journal of Cardiovascular Magnetic Resonance
                BioMed Central (London )
                1097-6647
                1532-429X
                20 January 2017
                20 January 2017
                2017
                : 19
                : 23
                Affiliations
                [1 ]ISNI 0000 0004 0378 8294, GRID grid.62560.37, , Department of Medicine, Brigham and Women’s Hospital, Cardiovascular Division, ; Boston, USA
                [2 ]ISNI 000000041936754X, GRID grid.38142.3c, , Harvard Medical School, ; 75 Francis Street, Boston, MA 02115 USA
                [3 ]ISNI 0000 0001 2171 1133, GRID grid.4868.2, , William Harvey Research Institute, ; London, UK
                [4 ]ISNI 0000 0001 2218 4662, GRID grid.6363.0, , Charite Universitatsmedizin, ; Berlin, Germany
                [5 ]ISNI 0000 0001 2293 4638, GRID grid.279885.9, , National Heart Lung and Blood Institute, ; Maryland, USA
                [6 ]Revere Health, Provo, USA
                [7 ]ISNI 0000 0004 1770 1022, GRID grid.412901.f, , West China Hospital, ; Chengdu, China
                [8 ]Miami Cardiac and Vascular Institute, Miami, USA
                [9 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, , University of Oxford, ; Oxford, UK
                [10 ]ISNI 0000 0001 0675 4725, GRID grid.239578.2, , Cleveland Clinic, ; Cleveland, USA
                [11 ]San Antonio Military Medical Center, San Antonio, USA
                [12 ]Oklahoma Heart Institute, Oklahoma, USA
                [13 ]ISNI 0000 0001 2353 285X, GRID grid.170693.a, , University of South Florida, ; Miami, USA
                [14 ]ISNI 0000 0001 1545 0811, GRID grid.412332.5, , Ohio State University Wexner Medical Center, ; Cleveland, USA
                [15 ]ISNI 0000 0004 1936 9000, GRID grid.21925.3d, , University of Pittsburgh, ; Pittsburgh, USA
                [16 ]ISNI 0000000419368657, GRID grid.17635.36, , University of Minnesota, ; Minnesota, USA
                [17 ]St. Francis Hospital, New York, USA
                [18 ]ISNI 0000 0004 0372 3343, GRID grid.9654.e, , University of Auckland, ; Auckland, New Zealand
                [19 ]ISNI 0000 0004 0386 9924, GRID grid.32224.35, , Massachusetts General Hospital, ; Boston, USA
                [20 ]ISNI 0000 0004 1936 8972, GRID grid.25879.31, , University of Pennsylvania, ; Philadelphia, USA
                [21 ]ISNI 0000 0001 2285 7943, GRID grid.261331.4, , Ohio State University, ; Columbus, USA
                Article
                321
                10.1186/s12968-016-0321-7
                5303267
                28187739
                8f40147d-68e0-46e6-a6e1-338d63dc281a
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 12 July 2016
                : 29 December 2016
                Funding
                Funded by: Society for Cardiovascular Magnetic Resonance
                Award ID: SCMR_GRANT_001
                Award Recipient :
                Categories
                Research
                Custom metadata
                © The Author(s) 2017

                Cardiovascular Medicine
                registry,cardiovascular magnetic resonance,imaging,patient management,therapeutic implications

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