Myocarditis Post Vaccination or Multi System Inflammatory Syndrome (MyoVax)

Hadassah Medical Center

Status: Enrolling

Conditions: Myocarditis

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05288426

DM005

Details and patient eligibility

About

BNT162b2 vaccine has become one of the most prevalent vaccines against the COVID-19 and is currently the main vaccine used in Israel. Since marketing and the beginning of use of the vaccine, we and others have reported. of the development of post vaccination myocarditis.

In this study the investigators wish to explore the long term impact on 150 patients who have been diagnosed with myocarditis or multisystem inflammatory syndrome (MIS) in the year following their diagnosis of Myocarditis.

Full description

Aim of Study

The primary aim of the study is to evaluate the impact of long term impact of myocarditis which has been developed secondary to Covid 19 vaccine or Covid 19 infection.

The primary end points of the study will be functional evaluations of the patients using clinical evaluation that includes questionnaires, ECG findings, evaluation of the systolic and diastolic function of the heart using echocardiogram or cardiac MRI, laboratory tests including troponin, CPK, CRP, Pro-BNP, and cytokines/chemokines.

Methods In this prospective study patients will be recruited from health care providers The selected patients will come to Hadassah hospital within 6 and 12 months after they have been diagnosed with myocarditis. Upon the patients arrival they will sign the informed consent, the investigators will draw blood tests and the participants will perform an echocardiogram according to the special protocol and will perform cardiac- MRI according to the myocarditis protocol. Patients will fulfill health questionnaires. that may include 36 Health Survey Questionnaire (SF-36); Scores on the European Quality of Life-5 Dimensions (EQ-5D) survey, which is also health-related quality of life score; the Scores on the European Quality of Life Visual Analogue Scale (EQ-VAS); Kansas City Cardiomyopathy Questionnaire (KCCQ). the Investigators will obtain blood samples from all the patients: complete blood count, c- reactive protein, troponin, CPK, Pro-BNP, liver and kidney functions, magnesium and cytokines. In addition, all participants will undergo echocardiogram test to evaluate their systolic and diastolic function of the heart.

Ethical Considerations

The study poses no danger to the participants. It has the potential to improve the understanding of the impact myocarditis post COVID-19 MRNA vaccine on the quality of life of those patients and provide a descent follow-up for the participant. Any participant will sign on informed consent form.

Enrollment: 150 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult males and females.
• Minors male and female.

Diagnosed as myocarditis:

• Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP)
• Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;
• Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) < 45%, or by cardiac magnetic resonance imaging.

Exclusion criteria

• Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from myocarditis, or otherwise suffer from valvuloplasty.
• Myocardial injury caused by sepsis, medical agents, or poisons;
• Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study

Trial design

150 participants in 4 patient groups

participant post first BNT162b2 vaccination

Description:

Patients which developed myocarditis after the first dose of BNT162b2 vaccination

Treatment:

Other: No intervention

participant post second BNT162b2 vaccination

Description:

Patients which developed myocarditis after the second dose of BNT162b2 vaccination

Treatment:

Other: No intervention

participant post third BNT162b2 vaccination

Description:

Patients which developed myocarditis after the third dose of BNT162b2 vaccination diagnosed with MIS

Treatment:

Other: No intervention

participant post COVID-19

Description:

Patients which developed myocarditis after COVID-19 infection

Treatment:

Other: No intervention