Official Title
Cardiovascular and Pulmonary Imaging in SARS-CoV-2: A Study of the Heart, Lungs and Wellbeing After COVID-19.
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.

Detailed Description

Our study is supported through the Chief Scientist Office Rapid Research in Covid-19
(RARC-19) programme. Our study will clarify the pathogenesis of cardiopulmonary injury,
notably endotypes of myocardial injury including myocarditis, in patients with COVID-19.

The study involves a prospective, observational, multicentre, longitudinal cohort design.The
investigators aim to minimise selection bias by adopting consecutive screening of all-comers
hospitalised with COVID-19 and the eligibility criteria are broad. For example, severe renal
dysfunction is not an exclusion criterion. The sample size is 180 patients enrolled at
baseline with 160 attending for the primary outcome evaluation (cardiac imaging) at 28 days
post-discharge. The investigators will use advanced cardiovascular imaging to identify the
number (proportion) of patients with myocardial inflammation (myocarditis) that is
sub-clinical (i.e. not diagnosed) or clinically overt. Cardiovascular MRI and CT coronary
angiography will provide a comprehensive examination one month after discharge is intended to
detect persisting cardiovascular complications and diagnose clinical endotypes. The
investigators aim to clarify the pathological significance of serial changes in circulating
troponin, NTproBNP and renal function. By correlating the MRI findings with troponin I and
other measures of cardiovascular injury, such as NTproBNP, our results will inform care
pathways that use these blood tests to guide the management of patients with COVID-19.
Correlation of imaging findings with baseline clinical information, biomarkers, patient
reported outcome measures and well-being in the longer term will help to clarify the clinical
significance of cardiovascular complications in COVID-19. Since the design is observational,
an interim analysis may be undertaken with the timing informed by the enrolment rate.

Longer term follow-up will include a 5-year visit, contingent on funding and ethics approval,
and electronic health record linkage of vital status and episodes of NHS care.

Enrolling by invitation
COVID
Eligibility Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

Royal Alexandra Hospital
Paisley, Renfrewshire, United Kingdom

Royal Infirmary
Glasgow, United Kingdom

Queen Elizabeth University Hospital
Glasgow, United Kingdom

Colin Berry, MBChB/PhD, Principal Investigator
University of Glasgow / NHS Greater Glasgow & Clyde

University of Glasgow
NCT Number