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

NCT04358029 | Completed

• 1 other identifier: GCO 20-0931
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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. 1.Patients who have been diagnosed with COVID-19 infection at Mount Sinai Hospital will be included.
2. 2.A cohort of 1000 influenza patients will also be evaluated for purpose of comparison.
3. 3.Were hospitalized for COVID-19 and who had an abnormal echocardiogram during hospitalization.
4. 4.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.

Conditions

COVID 19 Cardiac; COVID 16 Arrhythmia; COVID 19 Death

Keywords

COVID 19 Cardiac; Cardiac Arrhythmias COVID

Outcome Measures

Primary Outcomes (1)

• Frequency of cardiac arrhythmias

  To characterize the frequency of cardiac arrhythmias in patients with COVID-19 infection

  19 Months

Secondary Outcomes (2)

• Mode of death

  19 Months

• Number of recurrence of atrial arrhythmias

  19 months

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with COVID-19 infection at Mount Sinai Hospital will be included.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivek Reddy: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (11)

• 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

  BACKGROUND

• World Health Organization. (2020, April 20). WHO: Coronavirus 2019 Situation Reports. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/

  BACKGROUND

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 BACKGROUND

• Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

  PMID: 32004427 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Prog Cardiovasc Dis. 2020 May-Jun;63(3):390-391. doi: 10.1016/j.pcad.2020.03.001. Epub 2020 Mar 10. No abstract available.

  PMID: 32169400 BACKGROUND

• Hu H, Ma F, Wei X, Fang Y. Coronavirus fulminant myocarditis treated with glucocorticoid and human immunoglobulin. Eur Heart J. 2021 Jan 7;42(2):206. doi: 10.1093/eurheartj/ehaa190. No abstract available.

  PMID: 32176300 BACKGROUND

• Liu K, Fang YY, Deng Y, Liu W, Wang MF, Ma JP, Xiao W, Wang YN, Zhong MH, Li CH, Li GC, Liu HG. Clinical characteristics of novel coronavirus cases in tertiary hospitals in Hubei Province. Chin Med J (Engl). 2020 May 5;133(9):1025-1031. doi: 10.1097/CM9.0000000000000744.

  PMID: 32044814 BACKGROUND

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 BACKGROUND

• Traebert M, Dumotier B, Meister L, Hoffmann P, Dominguez-Estevez M, Suter W. Inhibition of hERG K+ currents by antimalarial drugs in stably transfected HEK293 cells. Eur J Pharmacol. 2004 Jan 19;484(1):41-8. doi: 10.1016/j.ejphar.2003.11.003.

  PMID: 14729380 BACKGROUND

• Turagam MK, Musikantow D, Goldman ME, Bassily-Marcus A, Chu E, Shivamurthy P, Lampert J, Kawamura I, Bokhari M, Whang W, Bier BA, Malick W, Hashemi H, Miller MA, Choudry S, Pumill C, Ruiz-Maya T, Hadley M, Giustino G, Koruth JS, Langan N, Sofi A, Dukkipati SR, Halperin JL, Fuster V, Kohli-Seth R, Reddy VY. Malignant Arrhythmias in Patients With COVID-19: Incidence, Mechanisms, and Outcomes. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008920. doi: 10.1161/CIRCEP.120.008920. Epub 2020 Oct 7.

  PMID: 33026892 RESULT

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Martin Goldman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Cardiac Arrhythmia Service, Mount Sinai Health System

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: April 9, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)