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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
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Brief 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.

Condition or disease
COVID 19 Cardiac COVID 16 Arrhythmia COVID 19 Death

Detailed 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).

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Group/Cohort
COVID-19 patients
Patients who have been diagnosed with COVID-19 infection at Mount Sinai Hospital
Influenza patients
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



Primary Outcome Measures :
  1. Frequency of cardiac arrhythmias [ Time Frame: 19 Months ]
    To characterize the frequency of cardiac arrhythmias in patients with COVID-19 infection


Secondary Outcome Measures :
  1. Mode of death [ Time Frame: 19 Months ]
    To characterize the mode of death in patients with COVID-19 infection

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been diagnosed with COVID-19 infection at Mount Sinai Hospital will be included.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Betsy Ellsworth, MSN 212-824-8902 betsy.ellsworth@mountsinai.org
Contact: Stephanie Harcum, MS 212 824 8927 stephanie.harcum@mountsinai.org

Locations
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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    betsy.ellsworth@mountsinai.org   
Principal Investigator: Vivek Reddy, MD         
Sponsors and Collaborators
Vivek Reddy
Investigators
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Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Martin Goldman, MD Icahn School of Medicine at Mount Sinai
Publications:
National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. (2020, April 17). CDC: Cases of Coronavirus Disease (COVID-19) in the U.S. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fcases-in-us.html
World Health Organization. (2020, April 20). WHO: Coronavirus 2019 Situation Reports. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Mount Sinai Health System, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04358029    
Other Study ID Numbers: GCO 20-0931
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
COVID 19 Cardiac
Cardiac Arrhythmias COVID
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes