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

NCT05282498 | Unknown DMC

• 1 other identifier: MYOVAx
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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-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

Myocarditis

Outcome Measures

Primary Outcomes (1)

• 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 \</=30 times upper limit of normal range (for the individual hospital), regardless of cardiac function on echo iii. Group 3. Patients with cardiac symptoms, elevated troponins \> 30 times upper limit of normal range (for the individual hospital), regardless of cardiac function on echo iv. Group 4. Myocarditis diagnosed according to CDC criteria not meeting above categories

  Cardiac MRI should be done within 2 weeks from presentation

Eligibility Criteria

• Age: 5 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• Known prior abnormal heart function
• Contraindication to cardiac MRI
• Any condition which the investigator believes will prevent adherence to study protocol

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• KK Women's and Children's Hospital: collaborator
• Changi General Hospital: collaborator
• Tan Tock Seng Hospital: collaborator
• Khoo Teck Puat Hospital: collaborator
• National University Hospital, Singapore: collaborator
• Sengkang General Hospital: collaborator
• Ng Teng Fong General Hospital: collaborator

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for biomarker analysis and whole genome sequencing

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Keong Khung Yeo, MBBS

CONTACT

6704 8963; yeo.khung.keong@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 16, 2022
• Study Start: November 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

SG (1)