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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05438472
Recruitment Status : Completed
First Posted : June 30, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment
Myocarditis Other: data collection in healthcare professionals with COVID-19 mRNA vaccine booster

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
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Study Type : Observational
Actual Enrollment : 835 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine (MACIS)
Actual Study Start Date : December 10, 2021
Actual Primary Completion Date : April 20, 2022
Actual Study Completion Date : April 20, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of participants developing symptoms after the COVID-19 booster [ Time Frame: Assessment at day 3 (48- 96h) post-vaccination ]
    Number of participants developing symptoms after the COVID-19 booster

  2. Number of participants with MRI abnormalities after COVID-19 booster [ Time Frame: Assessment at day 4 post-vaccination ]
    Number of participants with MRI abnormalities after COVID-19 booster

  3. Composite of major adverse cardiac events [ Time Frame: 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.

  4. Need for hospitalization [ Time Frame: At day 4 post-vaccination ]
    Need for hospitalization

  5. Need for medical treatment [ Time Frame: 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.

  6. hs-cTnT/I concentrations on day 4 [ Time Frame: At day 4 post-vaccination ]
    hs-cTnT/I concentrations on day 4

  7. Total sum of costs (CHF) [ Time Frame: 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.

  8. T cell reactivity [ Time Frame: Assessment at day 4 post-vaccination ]
    T cell reactivity (against the SARS-CoV2 Spike, protein, myosin) in EDTA blood


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05438472


Locations
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Switzerland
University Hospital Basel, Department of Cardiology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Christian Müller, Prof. Dr. med. University Hospital Basel, Department of Cardiology
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT05438472    
Other Study ID Numbers: 2021-02339; kt22Mueller
First Posted: June 30, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
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
Additional relevant MeSH terms:
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COVID-19
Myocarditis
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases