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

Borja Ibanez; Anthony H. Aletras; Andrew E. Arai; Hakan Arheden; Jeroen Bax; Colin Berry; Chiara Bucciarelli-Ducci; Pierre Croisille; Erica Dall'Armellina; Rohan Dharmakumar; Ingo Eitel; Rodrigo Fernández-Jiménez; Matthias G. Friedrich; David García-Dorado; Derek J. Hausenloy; Raymond J. Kim; Sebastian Kozerke; Christopher M. Kramer; Michael Salerno; Javier Sánchez-González; Javier Sanz; Valentin Fuster

doi:10.1016/j.jacc.2019.05.024

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

Borja Ibanez^*, Anthony H. Aletras, Andrew E. Arai, Hakan Arheden, Jeroen Bax, Colin Berry, Chiara Bucciarelli-Ducci, Pierre Croisille, Erica Dall'Armellina, Rohan Dharmakumar, Ingo Eitel, Rodrigo Fernández-Jiménez, Matthias G. Friedrich, David García-Dorado, Derek J. Hausenloy, Raymond J. Kim, Sebastian Kozerke, Christopher M. Kramer, Michael Salerno, Javier Sánchez-GonzálezJavier Sanz, Valentin Fuster

^*Korrespondierende/r Autor/-in für diese Arbeit

317 Zitate (Scopus)

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.

Originalsprache	Englisch
Zeitschrift	Journal of the American College of Cardiology
Jahrgang	74
Ausgabenummer	2
Seiten (von - bis)	238-256
Seitenumfang	19
ISSN	0735-1097
DOIs	https://doi.org/10.1016/j.jacc.2019.05.024
Publikationsstatus	Veröffentlicht - 16.07.2019

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The CNIC is supported by the ISCiii, MICINN, and the Pro CNIC Foundation, and is a Severo Ochoa Center of Excellence (award SEV-2015-0505). This research was supported (in part) by the Intramural Research Program of the National Institutes of Health, National Heart, Lung, and Blood Institute. Agencies supporting the research of coauthors are acknowledged in the Online Appendix. The authors appreciate the scientific commitment of the sponsor unrelated to industrial interests. Dr. Arai has a U.S. Government Cooperative Research and Development Agreement with Siements; has a U.S. Government Cooperative Research and Development Agreement (Clinical Trial Agreement) with Bayer; and has a U.S. Government official duty (unpaid consultant) with Circle CVI (licensed software developed at the National Institutes of Health). Dr. Arheden is a shareholder in Imacor AB. Dr. Bax has received speaker fees from Abbott Vascular and Boehringer Ingelheim; and his institution has received unrestricted research grants from Medtronic, Boston Scientific, Biotronik, Edwards Lifesciences, and GE Healthcare. Dr. Berry has institutional agreements between the University of Glasgow (employer) and Abbott Vascular, AstraZeneca, Coroventis, DalCor, GlaxoSmithKline, HeartFlow, Novartis, Philips, and Siemens Healthcare. Dr. Bucciarelli-Ducci has served as a consultant for Circle Cardiovascular Imaging. Dr. Dharmakumar has a research agreement with Siemens Healthcare. Dr. Friedrich has served as a board member and advisor for Circle Cardiovascular Imaging. Dr. Kim has received an educational grant from Siemens Healthineers; and is cofounder of HeartIT LLC. Dr. Salerno has received research support from Siemens Healthineers. Dr Croisille's institution holds a research agreement with Siemens Healthcare, Circle Cardiovascular Imaging, and Olea Medical. Dr. Sánchez-González is an employee of Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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Zentren: Universitäres Herzzentrum Lübeck (UHZL)

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2.22-12 Kardiologie, Angiologie

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10.1016/j.jacc.2019.05.024

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Ibanez, B., Aletras, A. H., Arai, A. E., Arheden, H., Bax, J., Berry, C., Bucciarelli-Ducci, C., Croisille, P., Dall'Armellina, E., Dharmakumar, R., Eitel, I., Fernández-Jiménez, R., Friedrich, M. G., García-Dorado, D., Hausenloy, D. J., Kim, R. J., Kozerke, S., Kramer, C. M., Salerno, M., ... Fuster, V. (2019). Cardiac MRI Endpoints in Myocardial Infarction Experimental and Clinical Trials: JACC Scientific Expert Panel. Journal of the American College of Cardiology, 74(2), 238-256. https://doi.org/10.1016/j.jacc.2019.05.024

@article{932f948190454b52a9d52391b3c4db99,

title = "Cardiac MRI Endpoints in Myocardial Infarction Experimental and Clinical Trials: JACC Scientific Expert Panel",

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.",

author = "Borja Ibanez and Aletras, \{Anthony H.\} and Arai, \{Andrew E.\} and Hakan Arheden and Jeroen Bax and Colin Berry and Chiara Bucciarelli-Ducci and Pierre Croisille and Erica Dall'Armellina and Rohan Dharmakumar and Ingo Eitel and Rodrigo Fern{\'a}ndez-Jim{\'e}nez and Friedrich, \{Matthias G.\} and David Garc{\'i}a-Dorado and Hausenloy, \{Derek J.\} and Kim, \{Raymond J.\} and Sebastian Kozerke and Kramer, \{Christopher M.\} and Michael Salerno and Javier S{\'a}nchez-Gonz{\'a}lez and Javier Sanz and Valentin Fuster",

note = "Funding Information: The CNIC is supported by the ISCiii, MICINN, and the Pro CNIC Foundation, and is a Severo Ochoa Center of Excellence (award SEV-2015-0505). This research was supported (in part) by the Intramural Research Program of the National Institutes of Health, National Heart, Lung, and Blood Institute. Agencies supporting the research of coauthors are acknowledged in the Online Appendix. The authors appreciate the scientific commitment of the sponsor unrelated to industrial interests. Dr. Arai has a U.S. Government Cooperative Research and Development Agreement with Siements; has a U.S. Government Cooperative Research and Development Agreement (Clinical Trial Agreement) with Bayer; and has a U.S. Government official duty (unpaid consultant) with Circle CVI (licensed software developed at the National Institutes of Health). Dr. Arheden is a shareholder in Imacor AB. Dr. Bax has received speaker fees from Abbott Vascular and Boehringer Ingelheim; and his institution has received unrestricted research grants from Medtronic, Boston Scientific, Biotronik, Edwards Lifesciences, and GE Healthcare. Dr. Berry has institutional agreements between the University of Glasgow (employer) and Abbott Vascular, AstraZeneca, Coroventis, DalCor, GlaxoSmithKline, HeartFlow, Novartis, Philips, and Siemens Healthcare. Dr. Bucciarelli-Ducci has served as a consultant for Circle Cardiovascular Imaging. Dr. Dharmakumar has a research agreement with Siemens Healthcare. Dr. Friedrich has served as a board member and advisor for Circle Cardiovascular Imaging. Dr. Kim has received an educational grant from Siemens Healthineers; and is cofounder of HeartIT LLC. Dr. Salerno has received research support from Siemens Healthineers. Dr Croisille's institution holds a research agreement with Siemens Healthcare, Circle Cardiovascular Imaging, and Olea Medical. Dr. S{\'a}nchez-Gonz{\'a}lez is an employee of Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: {\textcopyright} 2019 The Authors Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",

year = "2019",

month = jul,

day = "16",

doi = "10.1016/j.jacc.2019.05.024",

language = "English",

volume = "74",

pages = "238--256",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "2",

}

Ibanez, B, Aletras, AH, Arai, AE, Arheden, H, Bax, J, Berry, C, Bucciarelli-Ducci, C, Croisille, P, Dall'Armellina, E, Dharmakumar, R, Eitel, I, Fernández-Jiménez, R, Friedrich, MG, García-Dorado, D, Hausenloy, DJ, Kim, RJ, Kozerke, S, Kramer, CM, Salerno, M, Sánchez-González, J, Sanz, J & Fuster, V 2019, 'Cardiac MRI Endpoints in Myocardial Infarction Experimental and Clinical Trials: JACC Scientific Expert Panel', Journal of the American College of Cardiology, Jg. 74, Nr. 2, S. 238-256. https://doi.org/10.1016/j.jacc.2019.05.024

TY - JOUR

T1 - Cardiac MRI Endpoints in Myocardial Infarction Experimental and Clinical Trials: JACC Scientific Expert Panel

AU - Ibanez, Borja

AU - Aletras, Anthony H.

AU - Arai, Andrew E.

AU - Arheden, Hakan

AU - Bax, Jeroen

AU - Berry, Colin

AU - Bucciarelli-Ducci, Chiara

AU - Croisille, Pierre

AU - Dall'Armellina, Erica

AU - Dharmakumar, Rohan

AU - Eitel, Ingo

AU - Fernández-Jiménez, Rodrigo

AU - Friedrich, Matthias G.

AU - García-Dorado, David

AU - Hausenloy, Derek J.

AU - Kim, Raymond J.

AU - Kozerke, Sebastian

AU - Kramer, Christopher M.

AU - Salerno, Michael

AU - Sánchez-González, Javier

AU - Sanz, Javier

AU - Fuster, Valentin

N1 - Funding Information: The CNIC is supported by the ISCiii, MICINN, and the Pro CNIC Foundation, and is a Severo Ochoa Center of Excellence (award SEV-2015-0505). This research was supported (in part) by the Intramural Research Program of the National Institutes of Health, National Heart, Lung, and Blood Institute. Agencies supporting the research of coauthors are acknowledged in the Online Appendix. The authors appreciate the scientific commitment of the sponsor unrelated to industrial interests. Dr. Arai has a U.S. Government Cooperative Research and Development Agreement with Siements; has a U.S. Government Cooperative Research and Development Agreement (Clinical Trial Agreement) with Bayer; and has a U.S. Government official duty (unpaid consultant) with Circle CVI (licensed software developed at the National Institutes of Health). Dr. Arheden is a shareholder in Imacor AB. Dr. Bax has received speaker fees from Abbott Vascular and Boehringer Ingelheim; and his institution has received unrestricted research grants from Medtronic, Boston Scientific, Biotronik, Edwards Lifesciences, and GE Healthcare. Dr. Berry has institutional agreements between the University of Glasgow (employer) and Abbott Vascular, AstraZeneca, Coroventis, DalCor, GlaxoSmithKline, HeartFlow, Novartis, Philips, and Siemens Healthcare. Dr. Bucciarelli-Ducci has served as a consultant for Circle Cardiovascular Imaging. Dr. Dharmakumar has a research agreement with Siemens Healthcare. Dr. Friedrich has served as a board member and advisor for Circle Cardiovascular Imaging. Dr. Kim has received an educational grant from Siemens Healthineers; and is cofounder of HeartIT LLC. Dr. Salerno has received research support from Siemens Healthineers. Dr Croisille's institution holds a research agreement with Siemens Healthcare, Circle Cardiovascular Imaging, and Olea Medical. Dr. Sánchez-González is an employee of Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: © 2019 The Authors Copyright: Copyright 2019 Elsevier B.V., All rights reserved.

PY - 2019/7/16

Y1 - 2019/7/16

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85068082015

U2 - 10.1016/j.jacc.2019.05.024

DO - 10.1016/j.jacc.2019.05.024

M3 - Scientific review articles

C2 - 31296297

AN - SCOPUS:85068082015

SN - 0735-1097

VL - 74

SP - 238

EP - 256

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 2

ER -

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

Abstract

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