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      Cardiac MRI Endpoints in Myocardial Infarction Experimental and Clinical Trials : JACC Scientific Expert Panel

      research-article
      , MD, PhD a , b , c , , PhD d , e , , MD f , , MD e , , MD, PhD g , , MD, PhD h , , MD, PhD i , , MD, PhD j , , MD, DPhil k , , PhD l , , MD m , , MD, PhD a , b , n , , MD o , p , , MD, PhD b , q , , MD, PhD r , s , t , , MD u , , PhD v , , MD w , , MD, PhD, MS w , , PhD x , , MD a , n , , MD, PhD a , n
      Journal of the American College of Cardiology
      area at risk, clinical trial, edema, endpoint, infarct size, magnetic resonance imaging, myocardial infarction, STEMI

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          Abstract

          After a reperfused myocardial infarction (MI), dynamic tissue changes occur (edema, inflammation, microvascular obstruction, hemorrhage, cardiomyocyte necrosis, and ultimately replacement by fibrosis). The extension and magnitude of these changes contribute to long-term prognosis after MI. Cardiac magnetic resonance (CMR) is the gold-standard technique for noninvasive myocardial tissue characterization. CMR is also the preferred methodology for the identification of potential benefits associated with new cardioprotective strategies both in experimental and clinical trials. However, there is a wide heterogeneity in CMR methodologies used in experimental and clinical trials, including time of post-MI scan, acquisition protocols, and, more importantly, selection of endpoints. There is a need for standardization of these methodologies to improve the translation into a real clinical benefit. The main objective of this scientific expert panel consensus document is to provide recommendations for CMR endpoint selection in experimental and clinical trials based on pathophysiology and its association with hard outcomes.

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          Most cited references64

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          Gadolinium-based Contrast Agent Accumulates in the Brain Even in Subjects without Severe Renal Dysfunction: Evaluation of Autopsy Brain Specimens with Inductively Coupled Plasma Mass Spectroscopy.

          To use inductively coupled plasma mass spectroscopy (ICP-MS) to evaluate gadolinium accumulation in brain tissues, including the dentate nucleus (DN) and globus pallidus (GP), in subjects who received a gadolinium-based contrast agent (GBCA).
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            Prognostic significance and determinants of myocardial salvage assessed by cardiovascular magnetic resonance in acute reperfused myocardial infarction.

            The aim of the study was to determine the prognostic significance and determinants of myocardial salvage assessed by cardiovascular magnetic resonance (CMR) in reperfused ST-segment elevation myocardial infarction. In acute myocardial infarction, CMR can retrospectively detect the myocardium at risk and the irreversible injury. This allows for quantifying the extent of salvaged myocardium after reperfusion as a potential strong end point for clinical trials and outcome. We analyzed 208 consecutive ST-segment elevation myocardial infarction patients undergoing primary angioplasty or= median group (2.9% vs. 22.1%, p < 0.001). The stepwise Cox proportional hazards model revealed that the MSI was the strongest predictor of major adverse cardiovascular events at 6-month follow-up (p < 0.001). All prognostic clinical (symptom onset to reperfusion), angiographic (Thrombolysis In Myocardial Infarction flow grade before angioplasty), and electrocardiographic (ST-segment resolution) parameters showed significant correlations with the MSI (p < 0.001 for all). This study for the first time demonstrates that the MSI assessed by CMR predicts the outcome in acute reperfused ST-segment elevation myocardial infarction. Therefore, MSI assessment has important implications for patient prognosis as well as for the design of future trials intended to test new reperfusion therapy efficacy. (Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance-Impact on Outcome; NCT00952224).
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              Delayed enhancement and T2-weighted cardiovascular magnetic resonance imaging differentiate acute from chronic myocardial infarction.

              Delayed enhancement (DE) cardiovascular magnetic resonance (CMR) detects acute and chronic myocardial infarction (MI) by visualizing contrast media accumulation in infarcted segments. T2-weighted CMR depicts infarct-related myocardial edema as a marker of acute but not chronic myocardial injury. We investigated the clinical utility of an approach combining both techniques to differentiate acute from chronic MI. Seventy-three MI patients were studied in 2 groups. Group A consisted of 15 acute MI patients who were studied twice, on day 1 and 3 months after MI. In group B, 58 patients with acute or chronic MI underwent 1 CMR scan. T2-weighted and DE images of matched slices were acquired on a 1.5-T system. In group A, quantitative segmental and region of interest-based analyses were performed to observe signal changes between the acute and chronic phases. In group B, T2-weighted and DE images were examined visually by 2 blinded observers for the presence or absence of hyperintense areas in corresponding segments. For infarct localization, coronary angiography and/or ECG changes served as the reference standard. In group A, the contrast-to-noise ratio on T2-weighted images dropped in the infarcted segments from 2.7+/-1.1 on day 1 to 0.1+/-1.2 after 3 months (P<0.0001). There was no significant change in contrast-to-noise ratio in DE images (1.9+/-1.5 versus 1.3+/-1.0; P=NS). The qualitative assessment of T2-weighted and DE images in group B yielded a specificity of 96% to differentiate acute from chronic lesions. An imaging approach combining DE and T2-weighted CMR accurately differentiates acute from chronic MI.
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                Author and article information

                Journal
                8301365
                4429
                J Am Coll Cardiol
                J. Am. Coll. Cardiol.
                Journal of the American College of Cardiology
                0735-1097
                1558-3597
                21 May 2020
                16 July 2019
                15 July 2020
                : 74
                : 2
                : 238-256
                Affiliations
                [a ]Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain;
                [b ]CIBERCV, Madrid, Spain;
                [c ]Cardiology Department, IIS Fundación Jiménez Díaz Hospital, Madrid, Spain;
                [d ]Laboratory of Computing, Medical Informatics and Biomedical-Imaging Technologies, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece;
                [e ]Lund University, Department of Clinical Sciences Lund, Clinical Physiology, Skane University Hospital, Lund, Sweden;
                [f ]National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland;
                [g ]Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, the Netherlands;
                [h ]British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, and Golden Jubilee National Hospital, Clydebank, United Kingdom;
                [i ]Bristol Heart Institute, Bristol NIHR Cardiovascular Research Centre, University of Bristol and University Hospitals Bristol NHS Trust, Bristol, United Kingdom;
                [j ]University Lyon, UJM-Saint-Etienne, INSA, CNRS UMR 5520, INSERM U1206, CREATIS, F-42023, Saint-Etienne, France;
                [k ]Leeds Institute of Cardiovascular and Metabolic Medicine, Department of Biomedical Imaging Sciences, University of Leeds, Leeds, United Kingdom;
                [l ]Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, and Division of Cardiology, Department of Medicine, University of California, Los Angeles, California;
                [m ]University Heart Center Lübeck, Medical Clinic II (Cardiology/ Angiology/Intensive Care Medicine) and German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Lübeck, Germany;
                [n ]Cardiology Department, Icahn School of Medicine at Mount Sinai, New York, New York;
                [o ]Departments of Medicine & Diagnostic Radiology, McGill University, Montreal, Quebec, Canada;
                [p ]Department of Medicine, Heidelberg University, Heidelberg, Germany;
                [q ]Vall d’Hebron University Hospital and Research Institute, Universtat Autònoma de Barcelona, Barcelona, Spain;
                [r ]Cardiovascular & Metabolic Disorders Program, Duke-National University of Singapore Medical School, National Heart Research Institute Singapore, National Heart Centre, Yong Loo Lin School of Medicine, National University Singapore, Singapore;
                [s ]The Hatter Cardiovascular Institute, University College London, and The National Institute of Health Research University College London Hospitals Biomedical Research Centre, Research & Development, London, United Kingdom;
                [t ]Tecnologico de Monterrey, Centro de Biotecnologia-FEMSA, Nuevo Leon, Mexico;
                [u ]Duke Cardiovascular Magnetic Resonance Center, Division of Cardiology, and Department of Radiology, Duke University Medical Center, Durham, North Carolina;
                [v ]Institute for Biomedical Engineering, University and ETH Zurich, Zurich, Switzerland;
                [w ]Departments of Medicine and Radiology, University of Virginia Health System, Charlottesville, Virginia; and
                [x ]Philips Healthcare, Madrid, Spain.
                Author notes
                ADDRESS FOR CORRESPONDENCE: Dr. Borja Ibanez, Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), c/ Melchor Fernandez Almagro, 3, 28029 Madrid, Spain. bibanez@ 123456cnic.es . Twitter: @Borjaibanez1. OR Dr. Valentin Fuster, Mount Sinai School of Medicine, Cardiovascular Institute, One Gustave Levy Place, Box 1030, New York, New York 10029-6500. valentin.fuster@ 123456mountsinai.org . Twitter: @CNIC_CARDIO.
                Article
                NIHMS1594192
                10.1016/j.jacc.2019.05.024
                7363031
                31296297
                e7ce8e51-e330-403d-8999-35350562e3ab

                This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/).

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                Categories
                Article

                Cardiovascular Medicine
                area at risk,clinical trial,edema,endpoint,infarct size,magnetic resonance imaging,myocardial infarction,stemi

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