NCT04312490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

March 11, 2020

Last Update Submit

November 20, 2021

Conditions

Myocarditis Viral

Keywords

VIRAL MYOCARDITIS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Determine the distribution of mono- and co-infections between these viral agents.

    12 months

Study Arms (1)

patients

EXPERIMENTAL

all patients with myocarditis

Diagnostic Test: endomyocardial biopsy

Interventions

endomyocardial biopsyDIAGNOSTIC_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

Also known as: Quantitative real-time PCR, Restriction fragment length polymorphism-PCR for B19V genotyping, Histological and Immunohistochemistry analysis
patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • ischemic cardiomyopathy.
  • peripartum cardiomyopathy
  • valvular etiology of heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, 71526, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 29622952BACKGROUND

  • 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.

    PMID: 36068503DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 18, 2020

Study Start

September 16, 2019

Primary Completion

October 1, 2021

Study Completion

November 15, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)