Status:
UNKNOWN
Pathophysiologic Mechanism for MYOcarditis in COVID19 VAccinations ("MYOVAx" Study)
Lead Sponsor:
National Heart Centre Singapore
Collaborating Sponsors:
KK Women's and Children's Hospital
Changi General Hospital
Conditions:
Myocarditis
Eligibility:
All Genders
5-99 years
Brief Summary
The coronavirus disease 2019 (COVID-19) is an ongoing pandemic which has infected more than 160 million people and caused 3.4 million deaths worldwide till May 2021. With the recent rollout of COVID-1...
Detailed Description
This is a prospective cohort study of patients with confirmed COVID19 vaccine associated myocarditis (CVAM). Patients will be required to fulfil CDC criteria for probable myocarditis with an enriched ...
Eligibility Criteria
Inclusion
- All patients age admitted to inpatient wards of public hospitals with cardiovascular complaints of chest pain, breathlessness, and/or palpitations, who have prior COVID19 vaccination within 21 days and who meet probable or confirmed criteria for myocarditis according to CDC (Annex A).
- All patients age presented to outpatient clinics of public hospitals with complaints of chest pain, breathlessness, and/or palpitations accompanied with rise of cardiac Troponin biomarker, who have prior COVID19 vaccination within 30 days and who meet probable or confirmed criteria for myocarditis according to CDC (Annex A).
- Age \>/= 5. Patients under age 21 will need parental consent.
- Willing to adhere to study protocol and other study requirements
- Provide informed consent
- Women who are pregnant or are breastfeeding may be included but will not be offered cardiac MRI with contrast, for safety reasons.
Exclusion
- Known prior abnormal heart function
- Contraindication to cardiac MRI
- Any condition which the investigator believes will prevent adherence to study protocol
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05282498
Start Date
November 1 2021
End Date
December 31 2023
Last Update
April 13 2022
Active Locations (1)
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1
National Heart Centre Singapore
Singapore, Singapore, 169609