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Pathophysiologic Mechanism for MYOcarditis in COVID19 VAccinations ("MYOVAx" Study)

NCT05282498 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-04-13

No results posted yet for this study

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-19 vaccines globally and in Singapore, reports of rare but serious cardiovascular-related side effects started to appear. Although a link between adenovirus-based vaccines (AstraZeneca ChAdOx1 and J\&J Ad26.COV2.S) and cerebral venous sinus thrombosis (CVST) and immune thrombocytopenia has been widely reported, these vaccines are current not in use in Singapore. Yet, acute myocarditis and other cardiovascular symptoms has also been observed to be associated with the two mRNA-based vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) in-use in Singapore. In Singapore acute myocarditis is of particular concern with at least 12 cases reported by the Health Services Authority (HSA). The US FDA and EU authorities have confirmed there to be an association between the mRNA vaccines and myocarditis.The study aims to (1) To study possible mechanisms of COVID-19 vaccines in causing myocarditis in patients with confirmed vaccine-associated myocarditis (2) To risk stratify for vaccine-associated myocarditis in the at-risk population of young men (3) To identify potential preventative strategies to mitigate vaccine-associated myocarditis in high-risk individuals

Conditions

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    collaborator OTHER_GOV

  • Changi General Hospital

    collaborator OTHER

  • Tan Tock Seng Hospital

    collaborator OTHER

  • Khoo Teck Puat Hospital

    collaborator OTHER

  • National University Hospital, Singapore

    collaborator OTHER

  • Sengkang General Hospital

    collaborator OTHER

  • Ng Teng Fong General Hospital

    collaborator OTHER

  • National Heart Centre Singapore

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-09-30
Completion
2023-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282498 on ClinicalTrials.gov