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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04312490
Enrollment
51
Registered
2020-03-18
Start date
2019-09-16
Completion date
2021-11-15
Last updated
2021-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis Viral

Keywords

VIRAL MYOCARDITIS

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.

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.

Interventions

DIAGNOSTIC_TESTendomyocardial 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

Sponsors

Science and Technology Development Fund (STDF)
CollaboratorUNKNOWN
Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Prospective study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
prevalence of the most common viruses12 monthsour 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

MeasureTime frameDescription
Determine the distribution of mono- and co-infections between these viral agents.12 monthsUsing PCR techniques to detect if single infection or multiple viral infection per pateint

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026