Presentation, Clinical Course and Patterns of Myocardial Damage Due to Viral Myocarditis
1 other identifier
observational
18
1 country
1
Brief Summary
Presentation, Clinical Course and Patterns of Myocardial Damage due to Viral Myocarditis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedOctober 8, 2020
August 1, 2020
5 months
August 23, 2020
October 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
determination of the caustive organism
6 months
Study Arms (1)
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.
Interventions
ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.
Eligibility Criteria
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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shery Refaat Asaad
Asyut, 23123, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Ayman khairy, professor
Assiut University
- PRINCIPAL INVESTIGATOR
Mohamed El Mokhtar, professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 23, 2020
First Posted
August 27, 2020
Study Start
October 1, 2020
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
October 8, 2020
Record last verified: 2020-08