History of Changes for Study: NCT05438472

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

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Version	A	B	Submitted Date	Changes
1			June 29, 2022	None (earliest Version on record)

Study Identification


Unique Protocol ID:	2021-02339; kt22Mueller
Brief Title:	Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine (MACIS)
Official Title:	Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine (MACIS)
Secondary IDs:

Study Status


Record Verification:	June 2022
Overall Status:	Completed
Study Start:	December 10, 2021
Primary Completion:	April 20, 2022 [Actual]
Study Completion:	April 20, 2022 [Actual]

First Submitted:	June 29, 2022
First Submitted that Met QC Criteria:	June 29, 2022
First Posted:	June 30, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	June 29, 2022
Last Update Posted:	June 30, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	University Hospital, Basel, Switzerland
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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


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


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	835 [Actual]
Number of Groups/Cohorts	1

Groups and Interventions

Groups/Cohorts

Interventions

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

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


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


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.
Sampling Method:	Probability Sample
Minimum Age:	16 Years
Maximum Age:	65 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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/Locations


Study Officials:	Christian Müller, Prof. Dr. med. Principal Investigator University Hospital Basel, Department of Cardiology
Locations:	Switzerland
	University Hospital Basel, Department of Cardiology Basel, Switzerland, 4031

IPDSharing


Plan to Share IPD:

References


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