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

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

Study Overview

• Status: Unknown
• Conditions: Viral Myocarditis
• Intervention / Treatment: 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

1. Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 months.
2. 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 Type: Observational
• Enrollment (Anticipated): 18

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 23123
    • Recruiting
    • Shery Refaat Asaad
    • Contact: Shery Asaad, resident; Phone Number: 01270992244; Email: drshosho31'@yahoo.com
    • Contact: Ayman khairy, assistant professor; Phone Number: 01094438055; Email: Ayman.hassan@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients complained of symptoms of moderate to severe heart disease including atypical chest pain, fatigue, reduced physical capacity, recently occurring cardiac arrhythmia, and/or dyspnea on exertion suggesting myocardial inflammation.

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determination of the caustive organism	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.	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ayman khairy, professor, Assiut University; Principal Investigator: Mohamed El Mokhtar, professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Myocarditis
• Other Study ID Numbers: Viral myocarditis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No