Status:
COMPLETED
Cardiac Arrhythmias In Patients With Coronavirus Disease (COVID-19)
Lead Sponsor:
Vivek Reddy
Conditions:
COVID 19 Cardiac
COVID 16 Arrhythmia
Eligibility:
All Genders
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 evalu...
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)....
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT04358029
Start Date
April 9 2020
End Date
April 1 2023
Last Update
August 5 2024
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029