Clinical trial NCT04403607: Cardiac Imaging in SARS-CoV-2 (COVID-19)
Official title: Cardiovascular and Pulmonary Imaging in SARS-CoV-2: A Study of the Heart, Lungs and Wellbeing After COVID-19.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2020-05-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: The primary cardiac outcome is the proportion of patients with a diagnosis of myocardial inflammation (myocarditis).
timeFrame: 28 days after discharge from hospital
measure: The primary cardio-pulmonary outcome is the proportion of patients with thrombosis
timeFrame: 28 days after discharge from hospital
Secondary outcomes:
measure: Myocardial injury
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Myocardial stress
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Systemic inflammation
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Vascular injury
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Endothelial activation and haemostasis
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Fibrin lysis
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Coagulation
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Platelet count
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Renal function
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Quantify myocardial perfusion as a measure of coronary microvascular function
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Association of the primary outcome according to a prior history of cardiovascular disease or no history of prior cardiovascular disease.
timeFrame: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)
measure: Patient reported outcome measures (PROMS) - health status
timeFrame: 1 year
measure: PROMS - functional capacity
timeFrame: 1 year
Other outcomes:
measure: Cardiovascular science - vascular biology
timeFrame: 1 year
measure: Cardiovascular science - mathematical modelling
timeFrame: 1 year
measure: Cardiovascular science - pathology
timeFrame: 1 year
measure: Health outcomes (serious adverse events)
timeFrame: 20 years
Locations:
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
state: Renfrewshire
city: Glasgow
country: United Kingdom
facility: Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: University of Glasgow / NHS Greater Glasgow & Clyde
name: Colin Berry, MBChB/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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