MyocarditisMACISNCT05438472
Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine
An observational study of Myocarditis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study evaluates the incidence, patient characteristics and outcome of myocarditis after the COVID-19 mRNA vaccination in healthcare professionals. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocarditis
- What is being tested?
- data collection in healthcare professionals with COVID-19 mRNA vaccine booster
- Type of treatment
- Vaccines
- How many people
- 835 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Dec 2021to 20 Apr 2022
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a systematic approach to detect myocarditis at the University Hospital Basel will be included. The project population includes mainly healthcare workers, aged between 16-65.
Who may be able to join
- individuals working at the University Hospital Basel, Switzerland
- informed consent available
- 16-65 years old
Who cannot join
- Refusal to participate at the study
- Cardiac events or cardiac surgery within 30 days prior to study (as these could result in prolonged hs-cTnT elevations and interfere with the diagnosis of myocarditis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Cardiology
Basel, 4031
About this study
Official title: Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine (MACIS)
This study evaluates the incidence, patient characteristics and outcome of myocarditis after the COVID-19 mRNA vaccination in healthcare professionals.
Read the detailed description
Considering previous reports of cardiovascular adverse events, passive surveillance might not identify all myocarditis/myopericarditis cases after COVID-19 vaccination and it is possible that a mild/subclinical myocarditis might be much more prevalent in the population. This research project has three aims: first, provide novel insights regarding the incidence, patient characteristics and outcome of myocarditis. Second, provide a safety net by active surveillance for myocarditis, allowing early initiation of appropriate therapy. Third, provide reassurance to the public regarding myocarditis, as questions have been raised by critics of the pharmaceutical industry that Phase III studies performed by the pharmaceutical industry may have not appropriately captured adverse events.
This study is screening persons undergoing the COVID-19 mRNA booster vaccination of possible development of myocarditis. This approach in detecting myocarditis would help early initiation of the right treatment under close monitoring of the clinical course. Furthermore, this kind of study might also help understand the development of myocarditis and possibly the reasons for sex differences. Myocarditis suspicion is raised when patients present symptoms of acute chest discomfort, myalgia, fever/chills, abnormal ECG, increased concentrations of high-sensitivity cardiac troponin T (hs-cTnT), possibly supported by signs of cardiac inflammation in cMRI (myocardial oedema, myocardial/pericardial late gadolinium enhancement, pericardial effusion). Since the study is performed on health care professionals working in the University Hospital Basel, it is able to monitor more closely the possible side effects of the mRNA vaccination. Consecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a systematic approach to detect myocarditis at the University Hospital Basel will be included.
- Conditions
- Myocarditis
- Being tested
- data collection in healthcare professionals with COVID-19 mRNA vaccine booster
- Keywords
- Major Adverse Cardiac Events (MACE), COVID-19 vaccination, Comirnaty (Pfizer/BioNTech) mRNA vaccine, Moderna mRNA vaccine, myopericarditis, health care professionals, COVID-19 booster vaccination, vaccination-induced myocarditis
- Medical subject headings
- Myocarditis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection in healthcare professionals with COVID-19 mRNA vaccine boosterOther
Day 3 (48 - 96h) post COVID-19 mRNA booster: data collection on symptoms (chest pain, dyspnea, myalgia, fever, chills); blood sample for cardiomyocyte injury (hs-cTnT, hs-cTnI). If elevated hs-cTnT concentration, participant has to avoid strenuous exercise. Work-up on Day 4: clinical evaluation, ECG, 2. blood sampling for hs-cTnT. If hs-cTnT > 100 ng/l, cardiac magnetic resonance imaging is done for signs of cardiac inflammation. If hs-cTnT rises above upper limit but doesn't exceed 100 ng/l, clinical exam might be evaluated. In confirmed myocarditis, a clinical assessment (treatment, need for hospitalization, length of rhythm monitoring, rest) is evaluated by a cardiologist. Day 4: EDTA blood from all subjects with elevated troponin at day 3 post-vaccination is collected for pathomechanism of mRNA vaccine associated myocarditis. 1-month follow-up: questionnaire on predefined cardiac endpoints.
| Study group | Role | What they receive |
|---|---|---|
| healthcare professionals with COVID-19 mRNA vaccine booster | Consecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a systematic approach to detect myocarditis at the University Hospital Basel. The project population includes mainly healthcare workers, aged between 16-65, most of them with presumable no comorbidities. Baseline characteristics include age, divided in several groups (16-20 years, 21-25 years, 26-30 years, 31-35 years, 36-40 years, 41-45 years, 46-50 years, 51-55 years, 56-60 years, 61-65 years). Receives: Other: data collection in healthcare professionals with COVID-19 mRNA vaccine booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of myocarditis after mRNA COVID-19 mRNA booster vaccine
The primary endpoint is centrally adjudicated myocarditis after mRNA COVID-19 mRNA vaccine by a cardiologist according to current European Society of Cardiology (ESC) guidelines.
Measured: Assessment at day 3 (48- 96h) post-vaccination
Secondary outcomes (8)
Number of participants developing symptoms after the COVID-19 booster
Number of participants developing symptoms after the COVID-19 booster
Measured: Assessment at day 3 (48- 96h) post-vaccination
Number of participants with MRI abnormalities after COVID-19 booster
Number of participants with MRI abnormalities after COVID-19 booster
Measured: Assessment at day 4 post-vaccination
Composite of major adverse cardiac events
MACE is defined as a composite of acute heart failure (requiring admission to a hospital or intra-hospital transfer to the intensive care unit), cardiac death, life-threatening arrhythmia (cardiac arrest, sustained ventricular tachycardia, AV-block III), signs of left bundle branch block (LBBB) within 1 month after mRNA COVID-19 vaccination.
Measured: 1-month follow-up post-vaccination
Need for hospitalization
Need for hospitalization
Measured: At day 4 post-vaccination
Need for medical treatment
Medical treatment could include, nonsteroidal anti-inflammatory medication (NSAIDs), use of immunomodulatory therapy such as colchicine (in cases with presumed pericardial inflammation) and intravenous globulins or corticosteroids, paracetamol, or morphine.
Measured: At day 4 post-vaccination
hs-cTnT/I concentrations on day 4
hs-cTnT/I concentrations on day 4
Measured: At day 4 post-vaccination
Total sum of costs (CHF)
Total sum of costs from involved study personnel, blood sampling, material used and further diagnostic work-up and treatment to estimate the financial value related to future screening of individuals receiving mRNA vaccines.
Measured: 1-month follow-up post-vaccination
T cell reactivity
T cell reactivity (against the SARS-CoV2 Spike, protein, myosin) in EDTA blood
Measured: Assessment at day 4 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start10 Dec 2021
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
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.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Müller, Prof. Dr. med., Principal investigator, University Hospital Basel, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438472
- Sponsor's protocol ID
- 2021-02339; kt22Mueller
- Acronym
- MACIS
- Status last verified
- Jun 2022
- First submitted
- 29 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine (MACIS)
- ClinicalTrials.gov ID
- NCT05438472
- Acronym / sponsor ID
- MACIS / 2021-02339; kt22Mueller
- Conditions
- Myocarditis
- Keywords
- Major Adverse Cardiac Events (MACE), COVID-19 vaccination, Comirnaty (Pfizer/BioNTech) mRNA vaccine, Moderna mRNA vaccine, myopericarditis, health care professionals, COVID-19 booster vaccination, vaccination-induced myocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 30 Jun 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.
This study evaluates the incidence, patient characteristics and outcome of myocarditis after the COVID-19 mRNA vaccination in healthcare professionals.
Detailed description
Considering previous reports of cardiovascular adverse events, passive surveillance might not identify all myocarditis/myopericarditis cases after COVID-19 vaccination and it is possible that a mild/subclinical myocarditis might be much more prevalent in the population. This research project has three aims: first, provide novel insights regarding the incidence, patient characteristics and outcome of myocarditis. Second, provide a safety net by active surveillance for myocarditis, allowing early initiation of appropriate therapy. Third, provide reassurance to the public regarding myocarditis, as questions have been raised by critics of the pharmaceutical industry that Phase III studies performed by the pharmaceutical industry may have not appropriately captured adverse events.
This study is screening persons undergoing the COVID-19 mRNA booster vaccination of possible development of myocarditis. This approach in detecting myocarditis would help early initiation of the right treatment under close monitoring of the clinical course. Furthermore, this kind of study might also help understand the development of myocarditis and possibly the reasons for sex differences. Myocarditis suspicion is raised when patients present symptoms of acute chest discomfort, myalgia, fever/chills, abnormal ECG, increased concentrations of high-sensitivity cardiac troponin T (hs-cTnT), possibly supported by signs of cardiac inflammation in cMRI (myocardial oedema, myocardial/pericardial late gadolinium enhancement, pericardial effusion). Since the study is performed on health care professionals working in the University Hospital Basel, it is able to monitor more closely the possible side effects of the mRNA vaccination. Consecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a systematic approach to detect myocarditis at the University Hospital Basel will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthcare professionals with COVID-19 mRNA vaccine booster | – | Other: data collection in healthcare professionals with COVID-19 mRNA vaccine boosterConsecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a systematic approach to detect myocarditis at the University Hospital Basel. The project population includes mainly healthcare workers, aged between 16-65, most of them with presumable no comorbidities. Baseline characteristics include age, divided in several groups (16-20 years, 21-25 years, 26-30 years, 31-35 years, 36-40 years, 41-45 years, 46-50 years, 51-55 years, 56-60 years, 61-65 years). |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a systematic approach to detect myocarditis at the University Hospital Basel will be included. The project population includes mainly healthcare workers, aged between 16-65.
Key inclusion criteria (3 listed)
- individuals working at the University Hospital Basel, Switzerland
- informed consent available
- 16-65 years old
Key exclusion criteria (2 listed)
- Refusal to participate at the study
- Cardiac events or cardiac surgery within 30 days prior to study (as these could result in prolonged hs-cTnT elevations and interfere with the diagnosis of myocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collection in healthcare professionals with COVID-19 mRNA vaccine boosterDay 3 (48 - 96h) post COVID-19 mRNA booster: data collection on symptoms (chest pain, dyspnea, myalgia, fever, chills); blood sample for cardiomyocyte injury (hs-cTnT, hs-cTnI). If elevated hs-cTnT concentration, participant has to avoid strenuous exercise. Work-up on Day 4: clinical evaluation, ECG, 2. blood sampling for hs-cTnT. If hs-cTnT > 100 ng/l, cardiac magnetic resonance imaging is done for signs of cardiac inflammation. If hs-cTnT rises above upper limit but doesn't exceed 100 ng/l, clinical exam might be evaluated. In confirmed myocarditis, a clinical assessment (treatment, need for hospitalization, length of rhythm monitoring, rest) is evaluated by a cardiologist. Day 4: EDTA blood from all subjects with elevated troponin at day 3 post-vaccination is collected for pathomechanism of mRNA vaccine associated myocarditis. 1-month follow-up: questionnaire on predefined cardiac endpoints. | Other | healthcare professionals with COVID-19 mRNA vaccine booster |
Primary outcome
Incidence of myocarditis after mRNA COVID-19 mRNA booster vaccine
Time frame: Assessment at day 3 (48- 96h) post-vaccination
The primary endpoint is centrally adjudicated myocarditis after mRNA COVID-19 mRNA vaccine by a cardiologist according to current European Society of Cardiology (ESC) guidelines.
8 secondary outcomes
Number of participants developing symptoms after the COVID-19 booster
Time frame: Assessment at day 3 (48- 96h) post-vaccination
Number of participants with MRI abnormalities after COVID-19 booster
Time frame: Assessment at day 4 post-vaccination
Composite of major adverse cardiac events
Time frame: 1-month follow-up post-vaccination
Need for hospitalization
Time frame: At day 4 post-vaccination
Need for medical treatment
Time frame: At day 4 post-vaccination
hs-cTnT/I concentrations on day 4
Time frame: At day 4 post-vaccination
Total sum of costs (CHF)
Time frame: 1-month follow-up post-vaccination
T cell reactivity
Time frame: Assessment at day 4 post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 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.
Christian Müller, Prof. Dr. med. principal investigator
University Hospital Basel, Department of Cardiology
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 University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jun 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of myocarditis after mRNA COVID-19 mRNA booster vaccine (time frame: Assessment at day 3 (48- 96h) post-vaccination). 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 30 Jun 2022.