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

Myocarditis Clinical Trial

— MACIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438472
• Other study ID #: 2021-02339; kt22Mueller
• Status: Completed
• Start date: December 10, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the incidence, patient characteristics and outcome of myocarditis after the COVID-19 mRNA vaccination in healthcare professionals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: April 20, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Myocarditis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Cardiology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessment at day 3 (48- 96h) post-vaccination
Secondary	Number of participants developing symptoms after the COVID-19 booster	Number of participants developing symptoms after the COVID-19 booster	Assessment at day 3 (48- 96h) post-vaccination
Secondary	Number of participants with MRI abnormalities after COVID-19 booster	Number of participants with MRI abnormalities after COVID-19 booster	Assessment at day 4 post-vaccination
Secondary	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.	1-month follow-up post-vaccination
Secondary	Need for hospitalization	Need for hospitalization	At day 4 post-vaccination
Secondary	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.	At day 4 post-vaccination
Secondary	hs-cTnT/I concentrations on day 4	hs-cTnT/I concentrations on day 4	At day 4 post-vaccination
Secondary	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.	1-month follow-up post-vaccination
Secondary	T cell reactivity	T cell reactivity (against the SARS-CoV2 Spike, protein, myosin) in EDTA blood	Assessment at day 4 post-vaccination