Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine (MACIS)
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ClinicalTrials.gov Identifier: NCT05438472 |
Recruitment Status :
Completed
First Posted : June 30, 2022
Last Update Posted : June 30, 2022
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Tracking Information | |||||
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First Submitted Date | June 29, 2022 | ||||
First Posted Date | June 30, 2022 | ||||
Last Update Posted Date | June 30, 2022 | ||||
Actual Study Start Date | December 10, 2021 | ||||
Actual Primary Completion Date | April 20, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine | ||||
Official Title | Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine (MACIS) | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. | ||||
Condition | 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.
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Study Groups/Cohorts | 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).
Intervention: Other: data collection in healthcare professionals with COVID-19 mRNA vaccine booster
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
835 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | April 20, 2022 | ||||
Actual Primary Completion Date | April 20, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 16 Years to 65 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Switzerland | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT05438472 | ||||
Other Study ID Numbers | 2021-02339; kt22Mueller | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | University Hospital, Basel, Switzerland | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | University Hospital, Basel, Switzerland | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University Hospital, Basel, Switzerland | ||||
Verification Date | June 2022 |