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

Completed

• Conditions: Myocarditis
• Interventions: Other: data collection in healthcare professionals with COVID-19 mRNA vaccine booster

• Registration Number: NCT05438472
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2021-12-10
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-20
• Status Verified: 2022-06
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Last Update Submitted: 2022-06-29
• Study First Posted: 2022-06-30
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 835

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthcare professionals with COVID-19 mRNA vaccine booster	data collection in 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).

Primary Outcome Measures

Name	Time	Method
Incidence of myocarditis after mRNA COVID-19 mRNA booster vaccine	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants developing symptoms after the COVID-19 booster	Assessment at day 3 (48- 96h) post-vaccination	Number of participants developing symptoms after the COVID-19 booster
Number of participants with MRI abnormalities after COVID-19 booster	Assessment at day 4 post-vaccination	Number of participants with MRI abnormalities after COVID-19 booster
hs-cTnT/I concentrations on day 4	At day 4 post-vaccination	hs-cTnT/I concentrations on day 4
T cell reactivity	Assessment at day 4 post-vaccination	T cell reactivity (against the SARS-CoV2 Spike, protein, myosin) in EDTA blood
Composite of major adverse cardiac events	1-month follow-up post-vaccination	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.
Need for medical treatment	At day 4 post-vaccination	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.
Need for hospitalization	At day 4 post-vaccination	Need for hospitalization
Total sum of costs (CHF)	1-month follow-up post-vaccination	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.

Trial Locations

Locations (1)

University Hospital Basel, Department of Cardiology; 🇨🇭 Basel, Switzerland