Patterns of Arrhythmias and Conduction Block in COVID-19 Patients and Its Relation to Myocardial Injury Detected by Cardiac Magnetic Resonance

October 10, 2020 updated by: Ahmed Abdel Rahim Hassaan, Assiut University
Detection of the incidence and types of arrhythmia and conduction block in COVID - 19 patients Detection and description of CMR patterns of myocardial injury in COVID-19 patients with arrhythmias.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

COVID-19 has been declared a global pandemic by the World Health Organization and is responsible for hundreds of thousands of deaths worldwide.

Early reports from China suggested an overall cardiac arrhythmia incidence of 17% in patients hospitalized for COVID-19. A higher arrhythmia rate (44%) was observed in patients with COVID-19 admitted to the intensive care unit (ICU). However, details of the type and burden of arrhythmias in this population have not been elucidated.

Myocardial injury is common in patients with COVID-19, accounting for 7%-23% of reported cases in Wuhan, China. Among COVID-related myocardial injury, etiologies vary and can include myocarditis, myocardial infarction, sepsis-related myocardial injury, and/or stress induced cardiomyopathy. Myocardial injury is associated with high risk of developing all types of arrhythmia including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, and variable degrees of heart block. Sudden cardiac death was also reported.

The pathophysiology of COVID-19-related myocarditis is a combination of direct viral injury and cardiac damage due to the host's immune response. Although the pathophysiology of arrhythmias is still speculative, clinicians should provide prompt monitoring and treatment. The long term impact of COVID-19 myocarditis remains unknown

Meanwhile, cardiac magnetic resonance (CMR) imaging is an integral test in the diagnosis of myocardial injury. It can safely be used as a first-line diagnostic tool in the workup of myocardial injury associated with COVID-19.

Investigators believe that proper diagnosis and management of COVID 19 related arrhythmias and their etiology can lead to both in-hospital and long term reduction of morbidity and mortality of this dangerous presentation of the disease.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include 50 confirmed COVID-19 patients admitted to Assiut University Heart Centre and critical care unit, internal medicine department within the next 6 months complaining of arrhythmias and heart block. These patients will be followed-up for a period of 6 months after discharge.

Description

Inclusion Criteria:

  1. COVID 19 suspected patients presented by chest pain, dyspnea, chest discomfort &/or palpitations
  2. ECG changes (LBBB, PVCs, ventricular tachycardia, AF, atrial flutter, ST-T changes, and conduction defects).
  3. Increased inflammatory markers and / or Tropnin-I.

Exclusion Criteria:

  1. COVID 19 patients without ECG changes.
  2. Patients known to have the same pattern of arrhythmia or conduction system defects before Covid-19 infection.
  3. Patients contraindicated for CMR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the incidence of arrhythmia and conduction block in COVID-19 patients using Holter
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection of myocardial injury in COVID-19 patients using CMR.
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Doaa A Fouad, Doctorate, Assiut University
  • Principal Investigator: Alaa A El-Moniem, Doctorate, Assiut University
  • Principal Investigator: Mohamed A.H Abdelhafez, Doctorate, Assiut University
  • Principal Investigator: Shimaa S Khider, Doctorate, Assiut University
  • Principal Investigator: Ahmed AR Hassaan, bachelor, Assiut University
  • Principal Investigator: Maram M Shafiq, student, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

October 10, 2020

First Posted (ACTUAL)

October 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 10, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • arrhythmias in COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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