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OpenTrials
Completed

NCT Number: NCT04312490

Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis

Viral myocarditis has been recognized as a cause of congestive heart failure, however diagnosis and treatment represents a challenging process. Recently, there is an increasing frequency of different cardiotropic viruses in the clinical setting of myocarditis. The introduction of the new molecular techniques in analysing the etiologic agent of acute myocarditis has enhanced significantly the knowledge on the molecular epidemiology of these viruses. The etiology of patients admitted to our university hospital remains unclear. It is therefore important to identify the aetiology associated with myocardial infections.

The purpose of the present study is to analyze the prevalence of a broad spectrum of cardiotropic viruses, including enteroviruses, adenoviruses and parvo B19 virus, in adults with suspected myocarditis with special reference to B19 virus due to its increasing prevalence nowadays.

The results of this study will provide a very important information for the prevalent infectious viral agents in our university hospital which will guide treatment protocol.

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Key information

Conditions

Myocarditis Viral

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospitals

Asyut, 71526, Egypt

About this study

Objectives

  • There are almost no data regarding the relative prevalence of viral pathogens associated with myocarditis and the demographic and clinical features related to these infections in Egypt. Therefore, our main interest is to determine the prevalence of the most common viruses in clinically relevant (i.e., hospitalization- requiring) patients with acute or chronic myocarditis, using highly sensitive molecular techniques as the diagnostic tool.
  • Our second aim is to determine the distribution of mono- and coinfections between these viral agents.
  • Finally, to correlate between the microbiological findings in this study and patient characteristics including age, sex, clinical features, regional distribution, and degree of urbanization (determined on the basis of the size of the city and the density of the population) of the patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients with recent unexplained heart failure in last 3 months and diagnosed as myocarditis by cardiac magnetic resonance (CMR) after exclusion of ischemic (by coronary angio) or valvular (by detailed ECHO) causes.

Exclusion criteria

  • ischemic cardiomyopathy.
  • peripartum cardiomyopathy
  • valvular etiology of heart failure

Treatment and study plan

Endomyocardial biopsy

Diagnostic Test

Endomyocardial biopsies will be stained with Masson's trichrome as well as Giemsa and examined by light microscopy. For immunohistology, tissue sections will be treated with an avidin-biotinimmunoperoxidase method (Vectastain-Elite ABC Kit, Vector, Burlingame, Calif), with application of the following monoclonal antibodies: CD3 (T cells; Novocastra Laboratories, Newcastle, UK), CD68 (macrophages, natural killer cells; DAKO, Hamburg, Germany), and HLA-DR-α (DAKO, Hamburg, Germany

Other names: Quantitative real-time PCR, Restriction fragment length polymorphism-PCR for B19V genotyping, Histological and Immunohistochemistry analysis

Primary outcomes

  1. prevalence of the most common viruses

    Time frame: 12 months

    our main interest is to determine the prevalence of the most common viruses in clinically relevant (i.e., hospitalization- requiring) patients with acute or chronic myocarditis, using highly sensitive molecular techniques as the diagnostic tool.

Secondary outcomes

  1. Determine the distribution of mono- and co-infections between these viral agents.

    Time frame: 12 months

    Using PCR techniques to detect if single infection or multiple viral infection per pateint

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Science and Technology Development Fund (STDF)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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