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

Myocarditis Clinical Trial

— MYOVAx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282498
• Other study ID #: MYOVAx
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: National Heart Centre Singapore
• Contact: Keong Khung Yeo, MBBS
• Phone: 6704 8963
• Email: yeo.khung.keong[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 99 Years

Eligibility

Inclusion Criteria:

1. 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).

2. 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).

3. Age >/= 5. Patients under age 21 will need parental consent.

4. Willing to adhere to study protocol and other study requirements

5. Provide informed consent

6. Women who are pregnant or are breastfeeding may be included but will not be offered cardiac MRI with contrast, for safety reasons.

Exclusion Criteria:

1. Known prior abnormal heart function

2. Contraindication to cardiac MRI

3. Any condition which the investigator believes will prevent adherence to study protocol

Related Conditions & MeSH terms

• Myocarditis

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (8)

Lead Sponsor	Collaborator
National Heart Centre Singapore	Changi General Hospital, Khoo Teck Puat Hospital, KK Women's and Children's Hospital, National University Hospital, Singapore, Ng Teng Fong General Hospital, Sengkang General Hospital, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac MRI	Myocarditis will be grouped according to: i. Group 1. Patients with cardiac symptoms, elevated troponins and normal cardiac function on echo ii. Group 2. Patients with cardiac symptoms, elevated troponins	Cardiac MRI should be done within 2 weeks from presentation

External Links

•   CDC Advisory Committee on Immunization Practices (ACIP). COVID-19 mRNA vaccines in adolescents and young adults: benefit-risk discussion
•   CDC Advisory Committee on Immunization Practices (ACIP). Update on COVID-19 vaccine safety, including myocarditis after mRNA vaccines