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

• Conditions: Viral Myocarditis
• Interventions: 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.

• Registration Number: NCT04527835
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-23
• Study First Posted: 2020-08-27
• Study Start: 2020-10-01
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients suspected for viral myocarditis	ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Shery Refaat Asaad; 🇪🇬 Assiut, Egypt