Myocarditis Post Vaccination or Multi System Inflammatory Syndrome

Phase

N/A

Condition

Chest Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT05288426

DM005

Ages > 16
All Genders
Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adult males and females.
Minors male and female. Diagnosed as myocarditis:
Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNIand CK-MB and BNP or NT-pro-BNP)
Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/orsyncope;
Image for cardiac injury: marked diffused reduction in left ventricle wall movement,with dramatically decreased left ventricle ejection fraction (LVEF) < 45%, or bycardiac magnetic resonance imaging.

Exclusion

Exclusion Criteria:

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

Study Design

November 01, 2021

December 01, 2025

Study 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.

Connect with a study center

Hadassah Medical Center
Jerusalem, 91120
Israel
Active - Recruiting

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