Society for Cardiovascular Magnetic Resonance (SCMR) expert consensus for CMR imaging endpoints in clinical research : part I - analytical validation and clinical qualification

  • Cardiovascular disease remains a leading cause of morbidity and mortality globally. Changing natural history of the disease due to improved care of acute conditions and ageing population necessitates new strategies to tackle conditions which have more chronic and indolent course. These include an increased deployment of safe screening methods, life-long surveillance, and monitoring of both disease activity and tailored-treatment, by way of increasingly personalized medical care. Cardiovascular magnetic resonance (CMR) is a non-invasive, ionising radiation-free method, which can support a significant number of clinically relevant measurements and offers new opportunities to advance the state of art of diagnosis, prognosis and treatment. The objective of the SCMR Clinical Trial Taskforce was to summarizes the evidence to emphasize where currently CMR-guided clinical care can indeed translate into meaningful use and efficient deployment of resources results in meaningful and efficient use. The objective of the present initiative was to provide an appraisal of evidence on analytical validation, including the accuracy and precision, and clinical qualification of parameters in disease context, clarifying the strengths and weaknesses of the state of art, as well as the gaps in the current evidence This paper is complementary to the existing position papers on standardized acquisition and post-processing ensuring robustness and transferability for widespread use. Themed imaging-endpoint guidance on trial design to support drug-discovery or change in clinical practice (part II), will be presented in a follow-up paper in due course. As CMR continues to undergo rapid development, regular updates of the present recommendations are foreseen.
Metadaten
Author:Valentina O. Puntmann, Silvia Valbuena, Rocio Hinojar, Steffen Erhard Petersen, John P. Greenwood, Christopher M. Kramer, Raymond Y. Kwong, Gerry P. McCann, Colin Berry, Eike NagelORCiDGND
URN:urn:nbn:de:hebis:30:3-467712
DOI:https://doi.org/10.1186/s12968-018-0484-5
ISSN:1532-429X
ISSN:1097-6647
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/30231886
Parent Title (English):Journal of cardiovascular magnetic resonance
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Language:English
Year of Completion:2018
Date of first Publication:2018/09/20
Publishing Institution:Universit├Ątsbibliothek Johann Christian Senckenberg
Contributing Corporation:SCMR Clinical Trial Writing Group
Release Date:2018/09/27
Tag:Biomarker; Cardiac magnetic resonance; Imaging; Position paper; SCMR
Volume:20
Issue:1, Art. 67
Page Number:23
First Page:1
Last Page:23
Note:
Open Access: This 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.
HeBIS-PPN:439193710
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universit├Ątspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 4.0