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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04527835

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Viral Myocarditis	Diagnostic Test: ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.

Detailed Description

Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 months.
Determine the pattern of broad spectrum cardiotropic viruses in patients with acute HF within the last 3 months. These viruses like enteroviruses, adenoviruses and parvo B19 virus, HBV, HCV and Covid 19 virus due to its increased prevelance nowadays.

Study Design

Study Type:

Observational

Anticipated Enrollment :

18 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
patients suspected for viral myocarditis All patients admitted with unexplained heart failure in the last 3 months will be investigated for viral myocarditis by the use of 12 lead ECG, echocardiography, Cardiac MRI , coronary angiography, Endomyocardial biopsy ( optional ), serological tests including ELIZA,Extraction of nucleic acid, Determination of viral genome by using PCR., Quantitative real-time PCR to assess viral load, Immunohistochemistry analysis of EMB.	Diagnostic Test: ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB. ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.

Arm

Intervention/Treatment

patients suspected for viral myocarditis

All patients admitted with unexplained heart failure in the last 3 months will be investigated for viral myocarditis by the use of 12 lead ECG, echocardiography, Cardiac MRI , coronary angiography, Endomyocardial biopsy ( optional ), serological tests including ELIZA,Extraction of nucleic acid, Determination of viral genome by using PCR., Quantitative real-time PCR to assess viral load, Immunohistochemistry analysis of EMB.

Diagnostic Test: ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.

ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.

Outcome Measures

Primary Outcome Measures

Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 months [6 months]
All patients admitted with symptoms , signs and echocardiographic finding suggesting myocarditis within 3 months from start of the symptoms. as acute heart failure, arrhythmias, typical chest pain with ST segment deviation in ECG . dilated cardiomyopathy associated with normal Coronary Angiography, history of upper respiratory tract infection within the last 3 months. All will be investigated for determine the pattern of viral myocarditis in those patients

Secondary Outcome Measures

determination of the caustive organism [6 months]
1. Determine the pattern of broad spectrum cardiotropic viruses in patients with acute HF within the last 3 months. These viruses like enteroviruses, adenoviruses and parvo B19 virus, HBV, HCV and Covid 19 virus due to its increased prevelance nowadays.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: All patients admitted with symptoms , signs and echocardiographic finding suggesting myocarditis within 3 months from start of the symptoms. as acute heart failure, arrhythmias, typical chest pain with ST segment deviation in ECG . dilated cardiomyopathy associated with normal Coronary Angiography, history of upper respiratory tract infection within the last 3 months.

Exclusion Criteria:

Patients with significant coronary artery disease.
Patient with family history suggesting familial DCMP
Critically ill patients.
Patients who refuse to do coronary angiography . .
Patients with severe valvular heart disease.
Pregnant women
Patients with raised renal chemistry.
Echocardiographic finding showing LVEDD more than 6.5cm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shery Refaat Asaad	Assiut		Egypt	23123

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Ayman khairy, professor, Assiut University
Principal Investigator: Mohamed El Mokhtar, professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shery Refaat Asaad, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04527835

Other Study ID Numbers:

Viral myocarditis

First Posted:

Aug 27, 2020

Last Update Posted:

Oct 8, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocarditis

Study Results

No Results Posted as of Oct 8, 2020