Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine

NCT ID: NCT05438472

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 835 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-10
• Study Completion Date: 2022-04-20

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.

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

data collection in healthcare professionals with COVID-19 mRNA vaccine booster

Intervention Type: OTHER

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.

Interventions

data collection in healthcare professionals with COVID-19 mRNA vaccine booster

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Müller, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Department of Cardiology

Locations

University Hospital Basel, Department of Cardiology

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2021-02339; kt22Mueller

Identifier Type: -

Identifier Source: org_study_id