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

Myocarditis Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 subset of confirmed cases. Study team will consent patients diagnosed with probably or confirmed myocarditis based on CDC criteria. Of the criteria, all patients must have elevated cardiac troponins. Patients will need to have a prior history of COVID19 vaccination within 21 days prior to the onset of symptoms. Clinical data, blood for serology, spike protein and mRNA measurements, biomarkers including immune mediators and cytokines will be analysed. Whole genome sequencing will also be performed. Patients will also undergo cardiac MRI. Patient will have clinical follow up at month-6 and blood samples analysis will be repeated. Cardiac MRI will be repeated at month-6 for those whose initial cardiac MRI show evidence of myocarditis to evaluate for recovery. ;

Related Conditions & MeSH terms

• Myocarditis

• NCT number: NCT05282498
• Study type: Observational
• Source: National Heart Centre Singapore
• Contact: Keong Khung Yeo, MBBS
• Phone: 6704 8963
• Email: yeo.khung.keong@singhealth.com.sg
• Status: Recruiting
• Start date: November 1, 2021
• Completion date: December 31, 2023