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

NCT ID: NCT04312490

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2021-11-15

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.

Conditions

Myocarditis Viral

Keywords

VIRAL MYOCARDITIS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients

all patients with myocarditis

Group Type: EXPERIMENTAL

endomyocardial biopsy

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Quantitative real-time PCR; Restriction fragment length polymorphism-PCR for B19V genotyping; Histological and Immunohistochemistry analysis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Science and Technology Development Fund (STDF)

UNKNOWN

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ayman khairy Mohamed

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University Hospitals

Asyut, , Egypt

Countries

Egypt

References

Hassan AKM, Fouad DA, Refaiy A. Demographic features and prevalence of myocarditis in patients undergoing transarterial endomyocardial biopsy for unexplained cardiomyopathy. Egypt Heart J. 2017 Mar;69(1):29-35. doi: 10.1016/j.ehj.2016.09.005. Epub 2016 Oct 10.

Reference Type: BACKGROUND

PMID: 29622952 (View on PubMed)

Khidr SS, El-Mokhtar MA, Asaad SR, Hetta HF, Abdel-Rahim MH, Youssef AAA, Hassan AKM. Clinical course, viral etiology, and the diagnostic workup for patients with suspected myocarditis: a single-center prospective study. BMC Cardiovasc Disord. 2022 Sep 6;22(1):396. doi: 10.1186/s12872-022-02833-0.

Reference Type: DERIVED

PMID: 36068503 (View on PubMed)

Other Identifiers

26393

Identifier Type: -

Identifier Source: org_study_id