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

NHS Trust

Status: Unknown

Conditions: COVID

Study type: Observational

Funder types: Other

Identifiers

NCT04403607

GN20ID164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

COVID-19

Description:

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

Control

Description:

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.