Cardiac Arrhythmias In Patients With Coronavirus Disease (COVID-19)

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    10000
  • sponsor
    Vivek Reddy
Updated on 26 April 2022

Summary

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.

Description

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).

Details
Condition COVID 19 Cardiac, COVID 16 Arrhythmia, COVID 19 Death
Clinical Study IdentifierNCT04358029
SponsorVivek Reddy
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cohort 1 (Retrospective)
Patients who have been diagnosed with COVID-19 infection at Mount Sinai Hospital will be included
A cohort of 1000 influenza patients will also be evaluated for purpose of comparison
Cohort 2 (Prospective) up to 100 patients who
Were hospitalized for COVID-19 and who had an abnormal echocardiogram (~50 patients), defined as
Abnormal Left Ventricular function ( regional or global)
Abnormal Right Ventricular function
Pericardial effusion
Diastolic dysfunction III-IV
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

Retrospective: Individuals who have not been diagnosed with COVID-19 nor influenza
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
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