Symptom Burden, Coagulopathy and Heart Disease after Acute SARS- CoV-2 Infection in Primary Practice - Results from the Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland (SETANTA)

Abstract

Purpose: The aim of SETANTA (Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland) study was to investigate symptom burden and incidence of cardiac abnormalities after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/COVID-19 and correlate these results with immunological response and biomarkers of coagulation. Methods: SETANTA was a prospective, single-arm observational cross-sectional study in a primary practice setting, prospectively registered with ClinicalTrials.gov identifier: NCT04823182. Patients with recent COVID-19 infection ≥6 weeks and ≤12 months before enrolment were enrolled. Primary outcomes of interest were markers of cardiac injury detected by cardiac magnetic resonance imaging (MRI), including left ventricular ejection fraction, late gadolinium enhancement and pericardial abnormalities, and serum biomarker levels. Results: 100 patients (n= 129 approached) were included, 64% were female. Mean age was 45.2 years. The median (interquartile range) time interval between COVID-19 infection and enrolment was 189 [125, 246] days. 83% had at least one persistent symptom. 96% had positive serology for prior SARS-CoV-2 infection. Late gadolinium enhancement, pericardial effusion, was present in 2.2% and 8.3% respectively; left ventricular ejection fraction was below the normal reference limit in 17.4% of patients. Von Willebrand factor antigen was elevated in 32.7% of patients. Fibrinogen and D-Dimer levels were raised in 10.2% and 11.1% of patients, respectively. Conclusion: In a cohort of primary practice patients recently recovered from SARS-CoV-2 infection, prevalence of persistent symptoms and markers of abnormal coagulation were high, despite a lower frequency of abnormalities on cardiac MRI compared with prior reports of patients assessed in a hospital setting. Trial Registration: Clinicaltrials.gov, NCT04823182 (prospectively registered on 30th March 2021)