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Cardiovascular MRI in clinical trials: expanded applications through novel surrogate endpoints
  1. Alex Pitcher1,
  2. Deborah Ashby2,
  3. Paul Elliott3,
  4. Steffen E Petersen4
  1. 1Department of Cardiovascular Medicine, Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital, University of Oxford, Headington, Oxford, UK
  2. 2Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK
  3. 3Department of Epidemiology and Biostatistics, MRC-HPA Centre for Environment and Health, School of Public Health, Imperial College London, London, UK
  4. 4Centre for Advanced Cardiovascular Imaging, William Harvey Research Institute, Barts and the London NIHR Biomedical Research Unit, The London Chest Hospital, London, UK
  1. Correspondence to Dr Steffen E Petersen, Centre for Advanced Cardiovascular Imaging, William Harvey Research Institute, Barts and the London National Institute of Health Research Biomedical Research Unit, The London Chest Hospital, Bonner Road, London E2 9JX, UK; s.e.petersen{at}qmul.ac.uk

Abstract

Recent advances in cardiovascular magnetic resonance (CMR) now allow the accurate and reproducible measurement of many aspects of cardiac and vascular structure and function, with prognostic data emerging for several key imaging biomarkers. These biomarkers are increasingly used in the evaluation of new drugs, devices and lifestyle modifications for the prevention and treatment of cardiovascular disease. This review outlines a conceptual framework for the application of imaging biomarkers to clinical trials, highlights several important CMR techniques which are in use in randomised studies, and reviews certain aspects of trial design, conduct and interpretation in relation to the use of CMR.

  • Clinical trial
  • randomised clinical trial
  • cardiovascular magnetic resonance
  • cardiac magnetic resonance
  • MRI
  • clinical trials

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Footnotes

  • Funding AP is supported by the British Heart Foundation and the Oxford National Institute of Health Research (NIHR) Biomedical Research Centre. SEP is directly funded by the Barts and the London NIHR Cardiovascular Biomedical Research Unit. DA and PE are NIHR Senior Investigators and acknowledge support from the NIHR Comprehensive Biomedical Research Centre at Imperial College Healthcare NHS Trust.

  • Competing interests PE is a member of the UK Biobank Steering Committee and Chair of the UK Biobank Enhancements subgroup which is considering addition of CMR measurements in a subsample of UK Biobank participants. AP and SEP are involved in the design and conduct of clinical trials using CMR to evaluate new therapies, some of which involve some funding from the pharmaceutical industry.

  • Provenance and peer review Not commissioned; externally peer reviewed.