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J Cardiovasc Magn Reson. 2018 Sep 20;20(1):67. doi: 10.1186/s12968-018-0484-5.

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

Author information

1
Institute of Experimental and Translational Cardiovascular Imaging, Goethe University Hospital Frankfurt, Frankfurt, Germany.
2
Department of Cardiology, Goethe University Hospital Frankfurt, Frankfurt, Germany.
3
Department of Cardiology, University Hospital La Paz, Madrid, Germany.
4
Department of Cardiology, University Hospital Ramón y Cajal, Madrid, Spain.
5
William Harvey Research Institute, Queen Mary University of London, Barts and the London NIHR Biomedical Research Centre at Barts, London, UK.
6
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
7
Department of Medicine (Cardiology) and Radiology, Cardiovascular Imaging Center, University of Virginia Health System, Charlottesville, Virginia, USA.
8
Cardiovascular Division, Department of Medicine, Brigham and Womens' Hospital, Boston, Massachusetts, USA.
9
Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
10
the NIHR Leicester Cardiovascular Biomedical Centre, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.
11
British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
12
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
13
Institute of Experimental and Translational Cardiovascular Imaging, Goethe University Hospital Frankfurt, Frankfurt, Germany. eike.nagel@cardiac-imaging.org.

Abstract

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.

KEYWORDS:

Biomarker; Cardiac magnetic resonance; Imaging; Position paper; SCMR

PMID:
30231886
PMCID:
PMC6147157
DOI:
10.1186/s12968-018-0484-5
[Indexed for MEDLINE]
Free PMC Article

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