NCT04358029

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

Completed Last updated 5 August 2024

What this trial tests

trial in COVID 19 Cardiac in 4,000 participants. Completed in 1 April 2023.

Timeline

9 April 2020

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	Vivek Reddy
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,000
Start date	9 April 2020
Primary completion	1 April 2023
Estimated completion	1 April 2023
Sites	1 location across United States

Conditions studied

• COVID 19 Cardiac — all drugs for COVID 19 Cardiac →
• COVID 16 Arrhythmia — all drugs for COVID 16 Arrhythmia →
• COVID 19 Death — all drugs for COVID 19 Death →

Sponsor

Vivek Reddy

Who can join

Eligibility, any sex, with COVID 19 Cardiac or COVID 16 Arrhythmia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long COVID: post-acute sequelae of COVID-19 with a cardiovascular focus.
   Raman B, Bluemke DA, Lüscher TF, Neubauer S. · · 2022 · cited 444× · PMID 35176758 · DOI 10.1093/eurheartj/ehac031
2. Malignant Arrhythmias in Patients With COVID-19: Incidence, Mechanisms, and Outcomes.
   Turagam MK, Musikantow D, Goldman ME, Bassily-Marcus A, et al · · 2020 · cited 50× · PMID 33026892 · DOI 10.1161/circep.120.008920
3. Prognostic Value of Electrocardiographic QRS Diminution in Patients Hospitalized With COVID-19 or Influenza.
   Lampert J, Miller M, Halperin JL, Oates C, et al · · 2021 · cited 7× · PMID 34579830 · DOI 10.1016/j.amjcard.2021.07.048
4. Prognostic Value of Electrocardiographic QRS Diminution in Patients With COVID-19.
   Lampert J, Miller M, Halperin JL, Oates C, et al · · 2021 · cited 4× · PMID 33926663 · DOI 10.1016/j.jacc.2021.02.062
5. The COVID-19 Trial Finder.
   Sun Y, Butler A, Lin F, Liu H, et al · · 2021 · cited 4× · PMID 33216120 · DOI 10.1093/jamia/ocaa304