Clinical trial NCT05288426: Myocarditis Post Vaccination or Multi System Inflammatory Syndrome
Official title: Consequences of Post BNT162b2 Vaccine Myocarditis and Multiple Inflammatory Syndrome Myocarditis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocarditis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that were hospitalized at Hadassah Medical Center and other hospitals in Israel, with the diagnosis of myocarditis post COVID-19 or post BNT162b2 vaccine (as specified in the inclusion criteria).

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess troponin levels in patients that developed acute myocarditis
timeFrame: 3 years
measure: To assess PRO-BNP levels in patients that developed acute myocarditis
timeFrame: 3 years
measure: To assess CRP levels in patients that developed acute myocarditis
timeFrame: 3 years
measure: To assess cardiac MRI in patients that developed acute myocarditis
timeFrame: 3 years
measure: To assess echocardiogram in patients that developed acute myocarditis
timeFrame: 3 years
measure: To assess health quality by a questionnaire in patients that developed acute myocarditis
timeFrame: 3 years
measure: To assess heart failure questionnaire in patients that developed acute myocarditis
timeFrame: 3 years
Secondary outcomes:
measure: Cytokine in Patients after myocarditis
timeFrame: 3 years
measure: Chemokine in Patients after myocarditis
timeFrame: 3 years
measure: Hematopoietic Growth Factors (HGF)in patients after myocarditis
timeFrame: 3 years
measure: Complement in patients after myocarditis
timeFrame: 3 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Dror Mevorach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, Asleh R, Amir O, Meir K, Cohen D, Dichtiar R, Novick D, Hershkovitz Y, Dagan R, Leitersdorf I, Ben-Ami R, Miskin I, Saliba W, Muhsen K, Levi Y, Green MS, Keinan-Boker L, Alroy-Preis S. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 2021 Dec 2;385(23):2140-2149. doi: 10.1056/NEJMoa2109730. Epub 2021 Oct 6.
citation: Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.