Myocarditis ViralNCT04312490
Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis
A study testing endomyocardial biopsy in people with Myocarditis Viral, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis Viral
- What is being tested?
- endomyocardial biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Sep 2019to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ischemic cardiomyopathy.
- peripartum cardiomyopathy
- valvular etiology of heart failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myocarditis Viral
- Being tested
- endomyocardial biopsy
- Keywords
- VIRAL MYOCARDITIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endomyocardial biopsyDiagnostic test
Also called Quantitative real-time PCR, Restriction fragment length polymorphism-PCR for B19V genotyping, Histological and Immunohistochemistry analysis
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
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | all patients with myocarditis Receives: Diagnostic Test: endomyocardial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start16 Sep 2019
- Primary completion1 Oct 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocarditis ViralStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective study
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Technology Development Fund (STDF)
- Responsible party
- Principal investigator, Ayman khairy Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312490
- Sponsor's protocol ID
- 26393
- Status last verified
- Nov 2021
- First submitted
- 11 Mar 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29622952Khidr 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.
PubMed 36068503
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presentation, Patterns of Myocardial Damage, and Clinical Course of Viral Myocarditis
- ClinicalTrials.gov ID
- NCT04312490
- Acronym / sponsor ID
- 26393
- Conditions
- Myocarditis Viral
- Keywords
- VIRAL MYOCARDITIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Science and Technology Development Fund (STDF)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Diagnostic Test: endomyocardial biopsyall patients with myocarditis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- ischemic cardiomyopathy.
- peripartum cardiomyopathy
- valvular etiology of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endomyocardial biopsyAlso: Quantitative real-time PCR, Restriction fragment length polymorphism-PCR for B19V genotyping, Histological and Immunohistochemistry analysisEndomyocardial 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 | Diagnostic test | patients |
Primary outcome
prevalence of the most common viruses
Time frame: 12 months
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.
1 secondary outcome
Determine the distribution of mono- and co-infections between these viral agents.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Background: PubMed 29622952Hassan 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.
- Derived from this study: PubMed 36068503Khidr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endomyocardial biopsy in people with Myocarditis Viral, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of the most common viruses (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312490, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.