Cardiac Imaging in SARS-CoV-2 (COVID-19)

NCT04403607 | Unknown

• 1 other identifier: GN20ID164
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

One-in-four patients with COVID-19 pneumonia develop life-threatening heart problems. Through cardiovascular imaging and biomarkers analyses this study aims to evaluate whether COVID-19 infection results in heart injury. The investigators will also investigate which patients are at risk of heart injury as a result of COVID-19 and why only some patients suffer heart problems as a consequence of the infection. The study will also assess multisystem involvement including the lungs and kidneys.

Conditions

COVID

Outcome Measures

Primary Outcomes (2)

• The primary cardiac outcome is the proportion of patients with a diagnosis of myocardial inflammation (myocarditis).

  Myocardial inflammation (or myocarditis) will be revealed by cardiovascular magnetic resonance imaging (MRI) according to contemporary guidelines including the modified Lake Louise Criteria. The endotypes of myocardial injury are 1) myocardial inflammation due to 1.1) viral myocarditis, 1.2) ischaemia, or 1.3) stress (Takotsubo) cardiomyopathy, 2) myocardial infarction, 3) indeterminate, or 4) none. The final diagnosis will be a consensus-based determination by an expert panel. This information will provide insights into the incidence, nature, time-course and clinical significance of cardiovascular involvement in patients with COVID-19. The clinical significance of our findings will be assessed through associations with patient reported outcome measures (PROMS) and health outcomes in the longer term.

  28 days after discharge from hospital

• The primary cardio-pulmonary outcome is the proportion of patients with thrombosis

  Thrombosis of the right heart, pulmonary arteries and left heart will be determined contrast-enhanced CT chest, angiography and MRI.

  28 days after discharge from hospital

Secondary Outcomes (13)

• Myocardial injury

  28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

• Myocardial stress

  28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

• Systemic inflammation

  28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

• Vascular injury

  28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

• Endothelial activation and haemostasis

  28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

Other Outcomes (4)

• Cardiovascular science - vascular biology

  1 year

• Cardiovascular science - mathematical modelling

  1 year

• Cardiovascular science - pathology

  1 year

Study Arms (2)

COVID-19

Patients with confirmed COVID-19 meeting the eligibility criteria specified in the protocol.

Control

COVID-19 negative. Age/sex matched to the COVID-19 cohort. Age range 40-80 years. At least one cardiovascular risk factor by ASSIGN criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comers who have attended or admitted to hospital for COVID-19 and meet the eligibility criteria described

You may qualify if:

• History of hospital attendance or hospitalisation for COVID-19, confirmed by a clinical diagnosis, laboratory test e.g. PCR and/or a radiological test e.g. CT chest or chest X-ray
• Age 18 years or more
• Capacity to provide written informed consent
• Able to comply with study procedures

You may not qualify if:

• Contra-indication to CMR e.g. severe claustrophobia, metallic foreign body
• Lack of informed consent
• Women who are pregnant, breast-feeding or of child-bearing potential without a negative pregnancy test

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (3)

Royal Alexandra Hospital

Paisley, Renfrewshire, PA2 9PJ, United Kingdom

Location

Royal Infirmary

Glasgow, G31 2ER, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (10)

• Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, Madhur MS, Tomaszewski M, Maffia P, D'Acquisto F, Nicklin SA, Marian AJ, Nosalski R, Murray EC, Guzik B, Berry C, Touyz RM, Kreutz R, Wang DW, Bhella D, Sagliocco O, Crea F, Thomson EC, McInnes IB. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020 Aug 1;116(10):1666-1687. doi: 10.1093/cvr/cvaa106.

  PMID: 32352535 BACKGROUND

• Cosyns B, Lochy S, Luchian ML, Gimelli A, Pontone G, Allard SD, de Mey J, Rosseel P, Dweck M, Petersen SE, Edvardsen T. The role of cardiovascular imaging for myocardial injury in hospitalized COVID-19 patients. Eur Heart J Cardiovasc Imaging. 2020 Jul 1;21(7):709-714. doi: 10.1093/ehjci/jeaa136.

  PMID: 32391912 BACKGROUND

• Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.

  PMID: 23824828 BACKGROUND

• Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.

  PMID: 30545455 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.

  PMID: 30571511 BACKGROUND

• Sykes R, Morrow AJ, Mangion K, McConnachie A, McIntosh A, Roditi G, Peng L, Rooney C, Scott K, Stobo DB, Berry C, Church C, Bayes H; CISCO-19 investigators. Radiological abnormalities persist following COVID-19 and correlate with impaired health-related quality of life: a prospective cohort study of hospitalised patients. BMJ Open Respir Res. 2025 Feb 10;12(1):e001985. doi: 10.1136/bmjresp-2023-001985.

  PMID: 39929549 DERIVED

• Sykes RA, Neves KB, Alves-Lopes R, Caputo I, Fallon K, Jamieson NB, Kamdar A, Legrini A, Leslie H, McIntosh A, McConnachie A, Morrow A, McFarlane RW, Mangion K, McAbney J, Montezano AC, Touyz RM, Wood C, Berry C. Vascular mechanisms of post-COVID-19 conditions: Rho-kinase is a novel target for therapy. Eur Heart J Cardiovasc Pharmacother. 2023 Jun 2;9(4):371-386. doi: 10.1093/ehjcvp/pvad025.

  PMID: 37019821 DERIVED

• Sykes R, Morrow AJ, McConnachie A, Kamdar A, Bagot C, Bayes H, Blyth KG, Briscoe M, Bulluck H, Carrick D, Church C, Corcoran D, Delles C, Findlay I, Gibson VB, Gillespie L, Grieve D, Barrientos PH, Ho A, Lang NN, Lowe DJ, Lennie V, MacFarlane P, Mayne KJ, Mark P, McIntosh A, McGeoch R, McGinley C, Mckee C, Nordin S, Payne A, Rankin A, Robertson KE, Ryan N, Roditi GH, Sattar N, Stobo DB, Allwood-Spiers S, Touyz R, Veldtman G, Weeden S, Watkins S, Welsh P, Wereski R, Mangion K, Berry C. Adjudicated myocarditis and multisystem illness trajectory in healthcare workers post-COVID-19. Open Heart. 2023 Feb;10(1):e002192. doi: 10.1136/openhrt-2022-002192.

  PMID: 36822817 DERIVED

• Morrow AJ, Sykes R, McIntosh A, Kamdar A, Bagot C, Bayes HK, Blyth KG, Briscoe M, Bulluck H, Carrick D, Church C, Corcoran D, Findlay I, Gibson VB, Gillespie L, Grieve D, Hall Barrientos P, Ho A, Lang NN, Lennie V, Lowe DJ, Macfarlane PW, Mark PB, Mayne KJ, McConnachie A, McGeoch R, McGinley C, McKee C, Nordin S, Payne A, Rankin AJ, Robertson KE, Roditi G, Ryan N, Sattar N, Allwood-Spiers S, Stobo D, Touyz RM, Veldtman G, Watkins S, Weeden S, Weir RA, Welsh P, Wereski R; CISCO-19 Consortium; Mangion K, Berry C. A multisystem, cardio-renal investigation of post-COVID-19 illness. Nat Med. 2022 Jun;28(6):1303-1313. doi: 10.1038/s41591-022-01837-9. Epub 2022 May 23.

  PMID: 35606551 DERIVED

• Mangion K, Morrow A, Bagot C, Bayes H, Blyth KG, Church C, Corcoran D, Delles C, Gillespie L, Grieve D, Ho A, Kean S, Lang NN, Lennie V, Lowe DJ, Kellman P, Macfarlane PW, McConnachie A, Roditi G, Sykes R, Touyz RM, Sattar N, Wereski R, Wright S, Berry C. The Chief Scientist Office Cardiovascular and Pulmonary Imaging in SARS Coronavirus disease-19 (CISCO-19) study. Cardiovasc Res. 2020 Dec 1;116(14):2185-2196. doi: 10.1093/cvr/cvaa209.

  PMID: 32702087 DERIVED

Related Links

• Glasgow Clinical Trials Unit
• Chief Scientist Office, Scottish Government - Rapid Research in Covid-19 (RARC-19)

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be stored for biomarker analyses including DNA

Study Officials

• Colin Berry, MBChB/PhD

  University of Glasgow / NHS Greater Glasgow & Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 27, 2020
• Study Start: May 22, 2020
• Primary Completion: March 18, 2021
• Study Completion: May 1, 2023
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

GB (3)