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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT04312490
Collaborator
Science and Technology Development Fund (STDF) (Other)
51
1
1
26
2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: endomyocardial biopsy
N/A

Detailed Description

Objectives

  1. 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.

  2. Our second aim is to determine the distribution of mono- and coinfections between these viral agents.

  3. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective studyProspective study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis
Actual Study Start Date :
Sep 16, 2019
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: patients

all patients with myocarditis

Diagnostic Test: endomyocardial biopsy
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
  • Outcome Measures

    Primary Outcome Measures

    1. prevalence of the most common viruses [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 Outcome Measures

    1. Determine the distribution of mono- and co-infections between these viral agents. [12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Hospitals Assiut Egypt 71526

    Sponsors and Collaborators

    • Assiut University
    • Science and Technology Development Fund (STDF)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ayman khairy Mohamed, assistant professor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04312490
    Other Study ID Numbers:
    • 26393
    First Posted:
    Mar 18, 2020
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayman khairy Mohamed, assistant professor, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 23, 2021