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NCT04865900 Clinical Trial

Prevalence of Perimyocarditis After Covid-19 Vaccine

Covid19 Clinical Trial

Official title:
Prevalence of Perimyocarditis After Covid-19 Vaccine

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04865900
Other study ID # HYMC-0046-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 9, 2021
Est. completion date April 2022

Study information
Verified date April 2021
Source Hillel Yaffe Medical Center
Contact Elisabeth Mahajna, MA
Phone 972-4-7744695
Email liesma@hy.health.gov.il
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria: - Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19 Exclusion Criteria: - Patients infected with Covid19

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Laboratory Blood Tests
Blood tests to determine liver and kidney functioning, total blood count, and troponin levels
• ECG
ECG to determine heart rate and functioning
• PCR
PCR test to determine whether patient has Covid19
• Antibody test
Antibody test to determine level of antibodies to Covid19
• Echocardiography
If Troponin level elevated echocardiography to determine heart function
• MRI
If Troponin level elevated MRI to determine heart function

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Elevated Troponin Laboratory blood tests will be taken before and after Covid19 vaccination and compared. Troponin levels above normal range of 0.4 ng/ml will indicate possibility of perimyocarditis and patient will referred for additional testing. 4 weeks
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