The objective of the study is to estimate the frequency of cardiac arrhythmias and characterize the mode of death in patients with coronavirus disease (SARS-CoV-2; COVID-19). The study will also evaluate the long term cardiac outcomes in patients previously diagnosed with COVID-19. This is a single-center, retrospective/ prospective registry enrolling all COVID-19 positive patients at Mount Sinai Hospital. Cohort 1: Retrospective chart review: 1. Patients who have been diagnosed with COVID-19 infection at Mount Sinai Hospital will be included. 2. A cohort of 1000 influenza patients will also be evaluated for purpose of comparison. Cohort 2: Prospective data collection of 100 patients who: 1. Were hospitalized for COVID-19 and who had an abnormal echocardiogram during hospitalization. 2. A matched cohort (for age, gender, troponin level, and days since hospital discharge) who did not have abnormalities on their echocardiograms (or who did not undergo echocardiogram) to ascertain that in this unusual disease, subjects did not develop echo abnormalities following hospital discharge.
STUDY OBJECTIVE The objective of the study is to estimate the frequency of cardiac
arrhythmias and characterize the mode of death in patients with the novel coronavirus disease
(SARS-CoV-2; COVID-19). The study will also evaluate the long term cardiac outcomes in
patients previously diagnosed with COVID-19.
INTRODUCTION, RATIONALE The novel coronavirus (SARS-CoV-2) emerged in Wuhan, China, in late
2019 and has quickly become a pandemic, significantly impacting the health and economy of the
United States and the rest of the world. There are over 500,000 cases and 24,000 deaths
related to COVID-19 worldwide, with an estimated mortality rate ranging from 1-8%. The United
States has been impacted by this pandemic significantly with over 80,000 cases and thousands
of deaths reported; these numbers will continue to worsen.
Patients infected with COVID-19 can exhibit a wide range of clinical manifestations, ranging
from an asymptomatic state to mild upper respiratory symptoms (with low-grade fever) to
severe disease with hypoxia and acute respiratory distress syndrome (ARDS) type lung injury.
In the setting of hypoxemic respiratory failure, ground glass opacification on chest imaging
is found more than 50% of the time.
COVID-19 has the potential to cause myocardial injury with at least 17% found to have an
elevated troponin and 23% noted to have heart failure in a study of 191 inpatients from
Wuhan, China. The prevalence of heart failure was significantly higher among non-survivors
compared with survivors (52% vs. 12%). In a meta-analysis of 4 studies including a total of
341 patients, standardized mean difference of cardiac troponin I levels were significantly
higher in those with severe COVID-19 related illness compared to those with non-severe
disease (25.6, 95% CI 6.8-44.5). Furthermore, cases of fulminant myocarditis with cardiogenic
shock have also been reported, with associated atrial and ventricular arrhythmias. In a
recent report from Wuhan, China, 16.7% of hospitalized and 44.4% of ICU patients with
COVID-19 had cardiac arrhythmias. Given the potential sampling bias in sicker, hospitalized
patients with hypoxia and electrolyte abnormalities in the acute phase of severe illness can
potentiate cardiac arrhythmias, the exact arrhythmic risk related to COVID-19 in patients
with less severe illness or those who recover from the acute phase of the severe illness is
currently unknown.
Furthermore, as it is currently unclear what medications may be beneficial for patients with
COVID-19. Several medications eg: chloroquine, hydroxychloroquine, remdesivir, tocilizumab
etc. are currently being investigated. Hydroxychloroquine is known to block Kv11.1 (HERG) and
can cause drug-induced LQT. As such, these drugs are used concomitantly with other
antiarrhythmic drugs such as amiodarone, Tikosyn, sotalol etc. which can be associated with
QT prolongation requiring close EKG and cardiac monitoring. Improved characterization of
arrhythmia burden and mechanism of death is critical, primarily in guiding the need for
developing treatment strategies, additional arrhythmia monitoring and need to consider
advanced prevention strategies including the role of implantable cardioverter defibrillator
(ICD).
Inclusion Criteria:
Cohort 1 (Retrospective):
1. Patients who have been diagnosed with COVID-19 infection at Mount Sinai Hospital will
be included.
2. A cohort of 1000 influenza patients will also be evaluated for purpose of comparison.
Cohort 2 (Prospective) up to 100 patients who:
1. Were hospitalized for COVID-19 and who had an abnormal echocardiogram (~50 patients),
defined as:
1. Abnormal Left Ventricular function ( regional or global)
2. Abnormal Right Ventricular function
3. Pericardial effusion
4. Diastolic dysfunction III-IV
2. A matched cohort (~50 patients, matched for age, gender, troponin level, and days
since hospital discharge) who did not have abnormalities on their echocardiograms (or
who did not undergo echocardiogram) to ascertain that in this unusual disease,
subjects did not develop echo abnormalities following hospital discharge
Exclusion Criteria :
1. Retrospective: Individuals who have not been diagnosed with COVID-19 nor influenza.
2. Prospective: a.) Individuals who have not been diagnosed with COVID-19 b.) subjects
under the age of 18 years. c.) unwilling or unable to sign consent. d.) residing in a
long term care facility and unable to attend follow-up visit at MS. e.) no follow up
visit conducted post-COVID hospitalization.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Investigator: Betsy Ellsworth, MSN
Contact: 212-824-8902
betsy.ellsworth@mountsinai.org
Investigator: Vivek Reddy, MD
Betsy Ellsworth, MSN
212-824-8902
betsy.ellsworth@mountsinai.org
Stephanie Harcum, MS
212 824 8927
stephanie.harcum@mountsinai.org