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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04527835
Other study ID # Viral myocarditis
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date March 1, 2021

Study information

Verified date August 2020
Source Assiut University
Contact Shery Asaad, Resident
Phone 01270992244
Email drshosho31@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Shery Refaat Asaad Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
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