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

Myocarditis Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312490
• Other study ID #: 26393
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 15, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocarditis
• Myocarditis Viral

Intervention

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-a (DAKO, Hamburg, Germany

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Science and Technology Development Fund (STDF)

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of the most common viruses	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.	12 months
Secondary	Determine the distribution of mono- and co-infections between these viral agents.	Using PCR techniques to detect if single infection or multiple viral infection per pateint	12 months