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 evaluatewhether COVID-19 infection results in heart injury. The investigators will alsoinvestigate which patients are at risk of heart injury as a result of COVID-19 and whyonly some patients suffer heart problems as a consequence of the infection. The studywill 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.

Unknown status
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