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

Primary Purpose

Myocarditis Viral

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
endomyocardial biopsy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocarditis Viral focused on measuring VIRAL MYOCARDITIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients

Arm Description

all patients with myocarditis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2020
Last Updated
November 20, 2021
Sponsor
Assiut University
Collaborators
Science and Technology Development Fund (STDF)
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1. Study Identification

Unique Protocol Identification Number
NCT04312490
Brief Title
Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis
Official Title
Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
Science and Technology Development Fund (STDF)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocarditis Viral
Keywords
VIRAL MYOCARDITIS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
all patients with myocarditis
Intervention Type
Diagnostic Test
Intervention Name(s)
endomyocardial biopsy
Other Intervention Name(s)
Quantitative real-time PCR, Restriction fragment length polymorphism-PCR for B19V genotyping, Histological and Immunohistochemistry analysis
Intervention Description
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
Primary Outcome Measure Information:
Title
prevalence of the most common viruses
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Determine the distribution of mono- and co-infections between these viral agents.
Description
Using PCR techniques to detect if single infection or multiple viral infection per pateint
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Assiut University Hospitals
City
Assiut
ZIP/Postal Code
71526
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29622952
Citation
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.
Results Reference
background
PubMed Identifier
36068503
Citation
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.
Results Reference
derived

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

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