Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04584411
Other study ID # arrhythmias in COVID-19
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date January 1, 2024

Study information

Verified date October 2020
Source Assiut University
Contact Ahmed AR Hassaan, bachelor
Phone +201068115040
Email ahmed.hassaan1994@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date January 1, 2024
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cardiac Magnetic resonance imaging
The following basic sequences will be conducted: Cine imaging using SSFP sequence for cardiac structure and function. Tissue characterization imaging, T1 and T2. Myocardial perfusion imaging. Late gadolinium enhancement. Diagnosis of myocarditis will be based on the modified Lake Louise criteria: T2-weighted: any of the following standard T2 sequences: regional high signal standard T2 sequences: global signal intensity ratio (myocardium/skeletal muscle) =2 T2 mapping: increased T2 relaxation times T1-weighted: any of the following late enhancement imaging: non-ischemic (subepicardial or mid myocardial) late enhancement native T1 mapping: increased T1 relaxation times or extracellular volume supportive criteria: signs of pericarditis: effusion or pericardial late enhancement regional or global wall motion abnormalities[5]

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

A. Bhatla et al., "COVID-19 and Cardiac Arrhythmias," Hear. Rhythm, no. July, pp. 6-11, 2020, doi: 10.1016/j.hrthm.2020.06.016.

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.

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. Review. — View 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. Review. — View 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. 2020 Jul 3. doi: 10.2217/fca-2020-0082. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the incidence of arrhythmia and conduction block in COVID-19 patients using Holter baseline
Secondary Detection of myocardial injury in COVID-19 patients using CMR. baseline
See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3