Status:
UNKNOWN
Myocarditis Post Vaccination or Multi System Inflammatory Syndrome
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Myocarditis
Eligibility:
All Genders
16+ years
Brief Summary
BNT162b2 vaccine has become one of the most prevalent vaccines against the COVID-19 and is currently the main vaccine used in Israel. Since marketing and the beginning of use of the vaccine, we and ot...
Detailed Description
Aim of Study The primary aim of the study is to evaluate the impact of long term impact of myocarditis which has been developed secondary to Covid 19 vaccine or Covid 19 infection. The primary end p...
Eligibility Criteria
Inclusion
- Adult males and females.
- Minors male and female.
- Diagnosed as myocarditis:
- Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP)
- Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;
- Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) \< 45%, or by cardiac magnetic resonance imaging.
Exclusion
- Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from myocarditis, or otherwise suffer from valvuloplasty.
- Myocardial injury caused by sepsis, medical agents, or poisons;
- Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05288426
Start Date
November 1 2021
End Date
December 1 2025
Last Update
March 21 2022
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel, 91120