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Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: protocol design of COVID-HEART—a UK, multicentre, observational study

Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: protocol design of COVID-HEART—a UK, multicentre, observational study
Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: protocol design of COVID-HEART—a UK, multicentre, observational study
Background Although coronavirus disease 2019 (COVID-19) is primarily a respiratory illness, myocardial injury is increasingly reported and associated with adverse outcomes. However, the pathophysiology, extent of myocardial injury and clinical significance remains unclear. Methods COVID-HEART is a UK, multicentre, prospective, observational, longitudinal cohort study of patients with confirmed COVID-19 and elevated troponin (sex-specific > 99th centile). Baseline assessment will be whilst recovering in-hospital or recently discharged, and include cardiovascular magnetic resonance (CMR) imaging, quality of life (QoL) assessments, electrocardiogram (ECG), serum biomarkers and genetics. Assessment at 6-months includes repeat CMR, QoL assessments and 6-min walk test (6MWT). The CMR protocol includes cine imaging, T1/T2 mapping, aortic distensibility, late gadolinium enhancement (LGE), and adenosine stress myocardial perfusion imaging in selected patients. The main objectives of the study are to: (1) characterise the extent and nature of myocardial involvement in COVID-19 patients with an elevated troponin, (2) assess how cardiac involvement and clinical outcome associate with recognised risk factors for mortality (age, sex, ethnicity and comorbidities) and genetic factors, (3) evaluate if differences in myocardial recovery at 6 months are dependent on demographics, genetics and comorbidities, (4) understand the impact of recovery status at 6 months on patient-reported QoL and functional capacity. Discussion COVID-HEART will provide detailed characterisation of cardiac involvement, and its repair and recovery in relation to comorbidity, genetics, patient-reported QoL measures and functional capacity. Clinical Trial registration: ISRCTN 58667920. Registered 04 August 2020.
Cardiovascular disease, Cardiovascular magnetic resonance, Coronavirus, COVID-19, Myocardial infarction, Myocardial inflammation, myocardial injury, Myocardial repair, Myocarditis, Myopericarditis
1097-6647
Gorecka, Miroslawa
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McCann, Gerry P.
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Berry, Colin
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Ferreira, Vanessa M.
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Moon, James
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Miller, Christopher A.
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Chiribiri, Amedeo
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Prasad, Sanjay
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Bucciarelli-Ducci, Chiara
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Dawson, Dana
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Fontana, Marianna
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Macfarlane, Peter W.
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McConnachie, Alex
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Neubauer, Stefan
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Greenwood, John P.
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Swoboda, Peter
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Steeds, Richard
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Fairbairn, Timothy
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Flett, Andrew
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Green, Thomas
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Cole, Graham
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McDiarmid, Adam
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Bunce, Nicholas
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Bellenger, Nicholas
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Ninan, Tishi
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Alfakih, Khaled
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Moon, James
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the COVID-HEART investigators
Gorecka, Miroslawa
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McCann, Gerry P.
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Berry, Colin
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Ferreira, Vanessa M.
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Moon, James
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Miller, Christopher A.
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Chiribiri, Amedeo
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Prasad, Sanjay
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Dweck, Marc R.
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Bucciarelli-Ducci, Chiara
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Dawson, Dana
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Fontana, Marianna
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Macfarlane, Peter W.
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McConnachie, Alex
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Neubauer, Stefan
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Greenwood, John P.
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Swoboda, Peter
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Steeds, Richard
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Green, Thomas
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Cole, Graham
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McDiarmid, Adam
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Bunce, Nicholas
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Kanagala, Prathap
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Bellenger, Nicholas
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Ninan, Tishi
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Alfakih, Khaled
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Moon, James
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Gorecka, Miroslawa, McCann, Gerry P., Berry, Colin, Ferreira, Vanessa M., Moon, James and Miller, Christopher A. , the COVID-HEART investigators (2021) Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: protocol design of COVID-HEART—a UK, multicentre, observational study. Journal of Cardiovascular Magnetic Resonance, 23 (1), [77]. (doi:10.1186/s12968-021-00752-1).

Record type: Article

Abstract

Background Although coronavirus disease 2019 (COVID-19) is primarily a respiratory illness, myocardial injury is increasingly reported and associated with adverse outcomes. However, the pathophysiology, extent of myocardial injury and clinical significance remains unclear. Methods COVID-HEART is a UK, multicentre, prospective, observational, longitudinal cohort study of patients with confirmed COVID-19 and elevated troponin (sex-specific > 99th centile). Baseline assessment will be whilst recovering in-hospital or recently discharged, and include cardiovascular magnetic resonance (CMR) imaging, quality of life (QoL) assessments, electrocardiogram (ECG), serum biomarkers and genetics. Assessment at 6-months includes repeat CMR, QoL assessments and 6-min walk test (6MWT). The CMR protocol includes cine imaging, T1/T2 mapping, aortic distensibility, late gadolinium enhancement (LGE), and adenosine stress myocardial perfusion imaging in selected patients. The main objectives of the study are to: (1) characterise the extent and nature of myocardial involvement in COVID-19 patients with an elevated troponin, (2) assess how cardiac involvement and clinical outcome associate with recognised risk factors for mortality (age, sex, ethnicity and comorbidities) and genetic factors, (3) evaluate if differences in myocardial recovery at 6 months are dependent on demographics, genetics and comorbidities, (4) understand the impact of recovery status at 6 months on patient-reported QoL and functional capacity. Discussion COVID-HEART will provide detailed characterisation of cardiac involvement, and its repair and recovery in relation to comorbidity, genetics, patient-reported QoL measures and functional capacity. Clinical Trial registration: ISRCTN 58667920. Registered 04 August 2020.

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Accepted/In Press date: 2 April 2021
Published date: 10 June 2021
Additional Information: Funding Information: CB acknowledges British Heart Foundation support (RE/18/6134217). GPM is funded by a NIHR Research Professorship (RP-2017-08-ST2-007). CM is funded by a NIHR Clinician Scientist Award (CS-2015-15-003). VMF and SN acknowledge the NIHR Oxford BRC for support of this study. CBD is in part supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. Additional support was provided by the NIHR Leicester Biomedical Research Centre and the NIHR Leeds Clinical Research Facility. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. We thank the patients and staff who have supported this project. Dr. Warren J. Manning served as a Guest Editor for this manuscript. Study Management and Recruitment centres: Grant applicants : JP Greenwood (chief investigator), GP McCann, C Berry, M Dweck, J Moon, CM Miller, A Chiribiri, S Prasad, VM Ferreira, C Bucciarelli-Ducci, D Dawson. Data repository and statistical analysis : Glasgow Clinical Trials Unit. Senior study statistician: Prof A McConnachie, GCTU. Local Principle Investigators and Recruitment Centres : Prof John Greenwood, Leeds Teaching Hospitals NHS Trust, UK; Prof Gerry McCann, Glenfield Hospital, Leicester, UK; Prof Dana Dawson, Aberdeen Royal Infirmary, UK; Prof Marc Dweck, Royal Infirmary of Edinburgh, UK; Prof Vanessa Ferreira, John Radcliffe Hospital, Oxford, UK; Prof Colin Berry, Queen Elizabeth University Hospital, Glasgow, UK; Dr Peter Swoboda, Pinderfields Hospital, Wakefield, UK; Dr Richard Steeds, Queen Elizabeth Hospital, Birmingham, UK; Prof James Moon, UCL Hospital London, UK; Dr Christopher Miller, Wythenshawe Hospital, Manchester, UK; Dr Timothy Fairbairn, Liverpool Heart and Chest Hospital, UK; Dr Andrew Flett, Southampton General Hospital, UK; Prof Marianna Fontana, Royal Free Hospital, London, UK; Dr Thomas Green, Northumbria NHS Trust, UK; Prof Amedeo Chiribiri, St Thomas? Hospital, London, UK; Dr Chiara Bucciarelli-Ducci, University Hospitals Bristol and Weston NHS Trust, UK; Dr Graham Cole, Hammersmith Hospital, London, UK; Prof Sanjay Prasad, Royal Brompton Hospital, London, UK; Dr Adam McDiarmid, Freeman Hospital, Newcastle Upon Tyne, UK; Dr Nicholas Bunce, St Georges Hospital, London, UK; Dr Prathap Kanagala, Aintree University Hospital, Liverpool, UK; Prof Nicholas Bellenger, The Royal Devon and Exeter Hospital, UK; Dr Tishi Ninan, Swansea Bay University Hospital, UK; Dr Khaled Alfakih, Lewisham University Hospital, London, UK; Prof James Moon, St Bartholomew's Hospital, London, UK. Funding Information: CB acknowledges British Heart Foundation support (RE/18/6134217). GPM is funded by a NIHR Research Professorship (RP-2017-08-ST2-007). CM is funded by a NIHR Clinician Scientist Award (CS-2015-15-003). VMF and SN acknowledge the NIHR Oxford BRC for support of this study. CBD is in part supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. Additional support was provided by the NIHR Leicester Biomedical Research Centre and the NIHR Leeds Clinical Research Facility. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. We thank the patients and staff who have supported this project. Dr. Warren J. Manning served as a Guest Editor for this manuscript. Study Management and Recruitment centres: Grant applicants: JP Greenwood (chief investigator), GP McCann, C Berry, M Dweck, J Moon, CM Miller, A Chiribiri, S Prasad, VM Ferreira, C Bucciarelli-Ducci, D Dawson. Data repository and statistical analysis: Glasgow Clinical Trials Unit. Senior study statistician: Prof A McConnachie, GCTU. Local Principle Investigators and Recruitment Centres: Prof John Greenwood, Leeds Teaching Hospitals NHS Trust, UK; Prof Gerry McCann, Glenfield Hospital, Leicester, UK; Prof Dana Dawson, Aberdeen Royal Infirmary, UK; Prof Marc Dweck, Royal Infirmary of Edinburgh, UK; Prof Vanessa Ferreira, John Radcliffe Hospital, Oxford, UK; Prof Colin Berry, Queen Elizabeth University Hospital, Glasgow, UK; Dr Peter Swoboda, Pinderfields Hospital, Wakefield, UK; Dr Richard Steeds, Queen Elizabeth Hospital, Birmingham, UK; Prof James Moon, UCL Hospital London, UK; Dr Christopher Miller, Wythenshawe Hospital, Manchester, UK; Dr Timothy Fairbairn, Liverpool Heart and Chest Hospital, UK; Dr Andrew Flett, Southampton General Hospital, UK; Prof Marianna Fontana, Royal Free Hospital, London, UK; Dr Thomas Green, Northumbria NHS Trust, UK; Prof Amedeo Chiribiri, St Thomas’ Hospital, London, UK; Dr Chiara Bucciarelli-Ducci, University Hospitals Bristol and Weston NHS Trust, UK; Dr Graham Cole, Hammersmith Hospital, London, UK; Prof Sanjay Prasad, Royal Brompton Hospital, London, UK; Dr Adam McDiarmid, Freeman Hospital, Newcastle Upon Tyne, UK; Dr Nicholas Bunce, St Georges Hospital, London, UK; Dr Prathap Kanagala, Aintree University Hospital, Liverpool, UK; Prof Nicholas Bellenger, The Royal Devon and Exeter Hospital, UK; Dr Tishi Ninan, Swansea Bay University Hospital, UK; Dr Khaled Alfakih, Lewisham University Hospital, London, UK; Prof James Moon, St Bartholomew's Hospital, London, UK. Funding Information: COVID-HEART is funded by the National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI) COVID-19 Rapid Response Rolling Call (Grant Number COV0254), and sponsored by the University of Leeds, UK. The study has been endorsed by the British Society of Cardiovascular Magnetic Resonance (BSCMR) Research Group, and nationally prioritised, and received both BHF-NIHR Cardiovascular Partnership Flagship Status, and the NIHR Urgent Public Health Group identified it as an Urgent Public Health (UPH) study. Funding for the translation of the patient information leaflets into non-English languages was provided by the West Yorkshire and Humber Clinical Research Network (CV070). Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: Cardiovascular disease, Cardiovascular magnetic resonance, Coronavirus, COVID-19, Myocardial infarction, Myocardial inflammation, myocardial injury, Myocardial repair, Myocarditis, Myopericarditis

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Local EPrints ID: 456601
URI: http://eprints.soton.ac.uk/id/eprint/456601
ISSN: 1097-6647
PURE UUID: d8af3c22-57f2-4be8-af98-43fd0d8893bc

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Date deposited: 05 May 2022 16:49
Last modified: 17 Mar 2024 12:59

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Contributors

Author: Miroslawa Gorecka
Author: Gerry P. McCann
Author: Colin Berry
Author: Vanessa M. Ferreira
Author: James Moon
Author: Christopher A. Miller
Author: Amedeo Chiribiri
Author: Sanjay Prasad
Author: Marc R. Dweck
Author: Chiara Bucciarelli-Ducci
Author: Dana Dawson
Author: Marianna Fontana
Author: Peter W. Macfarlane
Author: Alex McConnachie
Author: Stefan Neubauer
Author: John P. Greenwood
Author: Peter Swoboda
Author: Richard Steeds
Author: Timothy Fairbairn
Author: Andrew Flett
Author: Thomas Green
Author: Graham Cole
Author: Adam McDiarmid
Author: Nicholas Bunce
Author: Prathap Kanagala
Author: Nicholas Bellenger
Author: Tishi Ninan
Author: Khaled Alfakih
Author: James Moon
Corporate Author: the COVID-HEART investigators

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