Cardiac Arrhythmias In Patients With Coronavirus Disease (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04358029|
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 13, 2021
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.
Retrospective chart review:
- 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.
Prospective data collection of 100 patients who:
- Were hospitalized for COVID-19 and who had an abnormal echocardiogram during hospitalization.
- 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.
|Condition or disease|
|COVID 19 Cardiac COVID 16 Arrhythmia COVID 19 Death|
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).
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Cardiac Arrhythmias In Patients With Coronavirus Disease (COVID-19)|
|Actual Study Start Date :||April 9, 2020|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Patients who have been diagnosed with COVID-19 infection at Mount Sinai Hospital
Patients who have been diagnosed with Influenza infection at Mount Sinai Hospital
COVID-19 patients who were hospitalized with abnormal echocardiogram
Patients hospitalized for COVID-19 and who had an abnormal echocardiogram during hospitalization
COVID-19 patients who were hospitalize with normal echocardiogram or no echocardiogram done
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
- Frequency of cardiac arrhythmias [ Time Frame: 19 Months ]To characterize the frequency of cardiac arrhythmias in patients with COVID-19 infection
- Mode of death [ Time Frame: 19 Months ]To characterize the mode of death in patients with COVID-19 infection
- Number of recurrence of atrial arrhythmias [ Time Frame: 19 months ]Number of recurrence of atrial arrhythmias in patients who manifested a new diagnosis atrial fibrillation or flutter while admitted with COVID-19 to evaluate long term cardiac outcomes in COVID-19 patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358029
|Contact: Betsy Ellsworth, MSNfirstname.lastname@example.org|
|Contact: Stephanie Harcum, MS||212 824 email@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Betsy Ellsworth, MSN 212-824-8902 firstname.lastname@example.org|
|Principal Investigator: Vivek Reddy, MD|
|Principal Investigator:||Vivek Reddy, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Martin Goldman, MD||Icahn School of Medicine at Mount Sinai|