MyocarditisMYOVAxNCT05282498
Pathophysiologic Mechanism for MYOcarditis in COVID19 VAccinations ("MYOVAx" Study)
An observational study of Myocarditis, run by National Heart Centre Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Myocarditis
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Known prior abnormal heart function
- Contraindication to cardiac MRI
- Any condition which the investigator believes will prevent adherence to study protocol
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Keong Khung Yeo, MBBS, 6704 8963 ext. 8963, yeo.khung.keong@singhealth.com.sg
About this study
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
Read the 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 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.
- Conditions
- Myocarditis
- Medical subject headings
- Myocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac MRI
Myocarditis will be grouped according to:
- 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
Measured: Cardiac MRI should be done within 2 weeks from presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Nov 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- KK Women's and Children's Hospital, Changi General Hospital, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, National University Hospital, Singapore, Sengkang General Hospital, Ng Teng Fong General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282498
- Sponsor's protocol ID
- MYOVAx
- Acronym
- MYOVAx
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiologic Mechanism for MYOcarditis in COVID19 VAccinations ("MYOVAx" Study)
- ClinicalTrials.gov ID
- NCT05282498
- Acronym / sponsor ID
- MYOVAx / MYOVAx
- Conditions
- Myocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- KK Women's and Children's Hospital, Changi General Hospital, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, National University Hospital, Singapore, Sengkang General Hospital, Ng Teng Fong General Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Known prior abnormal heart function
- Contraindication to cardiac MRI
- Any condition which the investigator believes will prevent adherence to study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac MRI
Time frame: Cardiac MRI should be done within 2 weeks from presentation
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis, run by National Heart Centre Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keong Khung Yeo, MBBS (6704 8963 ext. 8963, yeo.khung.keong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac MRI (time frame: Cardiac MRI should be done within 2 weeks from presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.