Clinical trial NCT04584411: Patterns of Arrhythmias and Conduction Block in COVID-19 Patients and Its Relation to Myocardial Injury Detected by Cardiac Magnetic Resonance
Official title: Patterns of Arrhythmias and Conduction Block in COVID-19 Patients and Its Relation to Myocardial Injury Detected by Cardiac Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the incidence of arrhythmia and conduction block in COVID-19 patients using Holter
timeFrame: baseline
Secondary outcomes:
measure: Detection of myocardial injury in COVID-19 patients using CMR.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Doaa A Fouad, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Alaa A El-Moniem, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Mohamed A.H Abdelhafez, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Shimaa S Khider, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ahmed AR Hassaan, bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Maram M Shafiq, student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pirzada A, Mokhtar AT, Moeller AD. COVID-19 and Myocarditis: What Do We Know So Far? CJC Open. 2020 May 28;2(4):278-285. doi: 10.1016/j.cjco.2020.05.005. eCollection 2020 Jul.
citation: Bhatla A, Mayer MM, Adusumalli S, Hyman MC, Oh E, Tierney A, Moss J, Chahal AA, Anesi G, Denduluri S, Domenico CM, Arkles J, Abella BS, Bullinga JR, Callans DJ, Dixit S, Epstein AE, Frankel DS, Garcia FC, Kumareswaram R, Nazarian S, Riley MP, Santangeli P, Schaller RD, Supple GE, Lin D, Marchlinski F, Deo R. COVID-19 and cardiac arrhythmias. Heart Rhythm. 2020 Sep;17(9):1439-1444. doi: 10.1016/j.hrthm.2020.06.016. Epub 2020 Jun 22.
citation: Shirazi S, Mami S, Mohtadi N, Ghaysouri A, Tavan H, Nazari A, Kokhazadeh T, Mollazadeh R. Sudden cardiac death in COVID-19 patients, a report of three cases. Future Cardiol. 2021 Jan;17(1):113-118. doi: 10.2217/fca-2020-0082. Epub 2020 Jul 3.
citation: B. Siripanthong et al., "Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID- company ' s public news and information website . Elsevier hereby grants permission to make all its COVID-19-r," no. January, 2020.
citation: Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.