Clinical trial NCT05438472: Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine
Official title: Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine (MACIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 835
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* individuals working at the University Hospital Basel, Switzerland
* informed consent available
* 16-65 years old

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of myocarditis after mRNA COVID-19 mRNA booster vaccine
timeFrame: Assessment at day 3 (48- 96h) post-vaccination
Secondary outcomes:
measure: Number of participants developing symptoms after the COVID-19 booster
timeFrame: Assessment at day 3 (48- 96h) post-vaccination
measure: Number of participants with MRI abnormalities after COVID-19 booster
timeFrame: Assessment at day 4 post-vaccination
measure: Composite of major adverse cardiac events
timeFrame: 1-month follow-up post-vaccination
measure: Need for hospitalization
timeFrame: At day 4 post-vaccination
measure: Need for medical treatment
timeFrame: At day 4 post-vaccination
measure: hs-cTnT/I concentrations on day 4
timeFrame: At day 4 post-vaccination
measure: Total sum of costs (CHF)
timeFrame: 1-month follow-up post-vaccination
measure: T cell reactivity
timeFrame: Assessment at day 4 post-vaccination
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Cardiology
Study officials:
affiliation: University Hospital Basel, Department of Cardiology
name: Christian Müller, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: