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

Valentina O Puntmann, Silvia Valbuena, Rocio Hinojar, Steffen E Petersen, John P Greenwood, Christopher M Kramer, Raymond Y Kwong, Gerry P McCann, Colin Berry, Eike Nagel, SCMR Clinical Trial Writing Group, Colin Berry, David Bluemke, Jens Bremerich, Rene Botnar, Chiara Bucciarelli-Ducci, Robin P Choudhury, Marc Dweck, Ingo Eitel, Vic Ferrari, Matthias Friedrich, John Greenwood, Rocio Hinojar, Greg Hundley, Christopher M Kramer, Raymond Y Kwong, Massimo Lombardi, Teresa Lopez Fernandez, Thomas Marwick, Eike Nagel, Jagat Narula, Stefan Neubauer, Amit Patel, Dudley Pennell, Steffen E Petersen, Sven Plein, Sanjay Prasad, Valentina O Puntmann, Frank Rademakers, Subha Raman, Hajime Sakuma, Javier Sanz, Jeannette Schulz-Menger, Orlando Simonetti, Andrew Swift, Andrew J Taylor, T Teixeira, Holger Thiele, Martin Ugander, Silvia Valbuena, Jos J Westenberg, Alistair A Young, Valentina O Puntmann, Silvia Valbuena, Rocio Hinojar, Steffen E Petersen, John P Greenwood, Christopher M Kramer, Raymond Y Kwong, Gerry P McCann, Colin Berry, Eike Nagel, SCMR Clinical Trial Writing Group, Colin Berry, David Bluemke, Jens Bremerich, Rene Botnar, Chiara Bucciarelli-Ducci, Robin P Choudhury, Marc Dweck, Ingo Eitel, Vic Ferrari, Matthias Friedrich, John Greenwood, Rocio Hinojar, Greg Hundley, Christopher M Kramer, Raymond Y Kwong, Massimo Lombardi, Teresa Lopez Fernandez, Thomas Marwick, Eike Nagel, Jagat Narula, Stefan Neubauer, Amit Patel, Dudley Pennell, Steffen E Petersen, Sven Plein, Sanjay Prasad, Valentina O Puntmann, Frank Rademakers, Subha Raman, Hajime Sakuma, Javier Sanz, Jeannette Schulz-Menger, Orlando Simonetti, Andrew Swift, Andrew J Taylor, T Teixeira, Holger Thiele, Martin Ugander, Silvia Valbuena, Jos J Westenberg, Alistair A Young

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.

Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This work represents an official publication of the SCMR and was approved by the SCMR Executive Committee. It did not undergo JCMR peer-review.

Figures

Fig. 1
Fig. 1
The illustration of reviewing steps involved in generation of this position paper. The manuscript structure, preparation and evidence appraisal procedures were based on a prior agreement within the SCMR Clinical Trial (CT) Writing Group (WG), as well as general guidance of the SCMR on Expert Consensus publications. Please see the Rationale for details

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