Myocarditis and CardiomyopathyMYOVACCNCT05268458
Myocarditis After SARS-CoV2-Vaccination
An observational study of Myocarditis and Cardiomyopathy, run by Theresien Hospital Mannheim at 1 site in Germany.
Trial summary
Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocarditis and Cardiomyopathy
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 12 Nov 2021to Jun 2022
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with SARS-CoV-2 Vaccine-associated Myocarditis.
Who may be able to join
- SARS-CoV-2 Vaccine-associated Myocarditis (< 30 days after vaccination) confirmed by cardiac MRI without evidence of alternative etiology (infectious, auto-immune myocarditis).
Who cannot join
- missing individual consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Theresienkrankenhaus
Mannheim, Baden-Wurttemberg, 65168
Marco Ochs, MD, m.ochs@theresienkrankenhaus.de
About this study
Official title: Myocarditis After SARS-CoV2-Vaccination: An International Patient Registry on Clinical Manifestations and Outcomes
Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide.
SARS-CoV-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of COVID-19. Large clinical trials have proven the safety and efficacy of the vaccines currently in use. Systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. Cases of myocarditis after vaccination have been reported for various vaccines. The new vaccines for SARS-CoV-2 also seem to be affected by this adverse reactions. The pathophysiology is uncertain so far.
Read more
Aim Aim of this study is a systematic registration of myocarditis cases associated with SARS-CoV-2 vaccination which were diagnosed and/or treated in participating centers. The main goal of this study is the characterization of clinical manifestations and prognosis of the disease.
Study Design Patient history, laboratory tests and cardiovascular imaging data of patients with suspected SARS-CoV-2 - vaccine associated myocarditis are documented. Patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving SARS-CoV-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. Clinical follow-up data is acquired.
- Conditions
- Myocarditis and Cardiomyopathy
- Keywords
- SARS CoV-19, Vaccination
- Medical subject headings
- Myocarditis, Cardiomyopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Primary Endpoint
Death, Hospitalization, symptomatic Heart Failure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start12 Nov 2021
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocarditis and CardiomyopathyStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Theresien Hospital Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, GRN Hospital Weinheim, GER, McGill University Health Care Montreal, CA, Foothills Medical Centre Calgary, CA, Sunnybrooks Research Institute Toronto, CA, Unity Health St. Michael's Hospital Toronto, CA
- Responsible party
- Principal investigator, Marco Ochs, Theresien Hospital Mannheim
- Investigators
- Marco Ochs, MD, Principal investigator, Theresien Hospital Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268458
- Sponsor's protocol ID
- TKH-032022-001
- Acronym
- MYOVACC
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schroth D, Garg R, Bocova X, Hansmann J, Haass M, Yan A, Fernando C, Chacko B, Oikonomou A, White J, Alhussein MM, Giusca S, Ochs A, Korosoglou G, Andre F, Friedrich MG, Ochs M. Predictors of persistent symptoms after mRNA SARS-CoV-2 vaccine-related myocarditis (myovacc registry). Front Cardiovasc Med. 2023 Jun 21;10:1204232. doi: 10.3389/fcvm.2023.1204232. eCollection 2023.
PubMed 37416926
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocarditis After SARS-CoV2-Vaccination: An International Patient Registry on Clinical Manifestations and Outcomes
- ClinicalTrials.gov ID
- NCT05268458
- Acronym / sponsor ID
- MYOVACC / TKH-032022-001
- Conditions
- Myocarditis and Cardiomyopathy
- Keywords
- SARS CoV-19, Vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Theresien Hospital MannheimUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, GRN Hospital Weinheim, GER, McGill University Health Care Montreal, CA, Foothills Medical Centre Calgary, CA, Sunnybrooks Research Institute Toronto, CA, Unity Health St. Michael's Hospital Toronto, CA
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 7 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.
Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide.
SARS-CoV-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of COVID-19. Large clinical trials have proven the safety and efficacy of the vaccines currently in use. Systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. Cases of myocarditis after vaccination have been reported for various vaccines. The new vaccines for SARS-CoV-2 also seem to be affected by this adverse reactions. The pathophysiology is uncertain so far.
Aim Aim of this study is a systematic registration of myocarditis cases associated with SARS-CoV-2 vaccination which were diagnosed and/or treated in participating centers. The main goal of this study is the characterization of clinical manifestations and prognosis of the disease.
Study Design Patient history, laboratory tests and cardiovascular imaging data of patients with suspected SARS-CoV-2 - vaccine associated myocarditis are documented. Patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving SARS-CoV-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. Clinical follow-up data is acquired.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with SARS-CoV-2 Vaccine-associated Myocarditis.
Key inclusion criteria (1 listed)
- SARS-CoV-2 Vaccine-associated Myocarditis (< 30 days after vaccination) confirmed by cardiac MRI without evidence of alternative etiology (infectious, auto-immune myocarditis).
Key exclusion criteria (1 listed)
- missing individual consent
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
Combined Primary Endpoint
Time frame: 6 months
Death, Hospitalization, symptomatic Heart Failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Derived from this study: PubMed 37416926Schroth D, Garg R, Bocova X, Hansmann J, Haass M, Yan A, Fernando C, Chacko B, Oikonomou A, White J, Alhussein MM, Giusca S, Ochs A, Korosoglou G, Andre F, Friedrich MG, Ochs M. Predictors of persistent symptoms after mRNA SARS-CoV-2 vaccine-related myocarditis (myovacc registry). Front Cardiovasc Med. 2023 Jun 21;10:1204232. doi: 10.3389/fcvm.2023.1204232. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Marco Ochs, MD principal investigator
Theresien Hospital Mannheim
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 and Cardiomyopathy, run by Theresien Hospital Mannheim at 1 site in Germany.
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 1 inclusion and 1 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 7 Mar 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 Germany. 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 Marco Ochs, MD (49621/424-4268, m.ochs@theresienkrankenhaus.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Primary Endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05268458, which also lists 1 linked publication.
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 7 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.