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

NCT05438472 | Completed

• 1 other identifier: 2021-02339; kt22Mueller
• Study Type: observational
• Target: 835
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of participants developing symptoms after the COVID-19 booster

  Assessment at day 3 (48- 96h) post-vaccination

• Number of participants with MRI abnormalities after COVID-19 booster

  Assessment at day 4 post-vaccination

• Composite of major adverse cardiac events

  1-month follow-up post-vaccination

• Need for hospitalization

  At day 4 post-vaccination

• Need for medical treatment

  At day 4 post-vaccination

Study Arms (1)

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

Interventions

data collection in healthcare professionals with COVID-19 mRNA vaccine booster OTHER

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.

healthcare professionals with COVID-19 mRNA vaccine booster

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• individuals working at the University Hospital Basel, Switzerland
• informed consent available
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Department of Cardiology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Myocarditis; Cardiovascular Diseases

Interventions

Data Collection; Health Personnel

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Care Facilities Workforce and Services

Study Officials

• Christian Müller, Prof. Dr. med.

  University Hospital Basel, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: June 30, 2022
• Study Start: December 10, 2021
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

CH (1)