Myocarditis Post Vaccination or Multi System Inflammatory Syndrome (MyoVax)

Consequences of Post BNT162b2 Vaccine Myocarditis and Multiple Inflammatory Syndrome Myocarditis

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.

Study Overview

• Status: Recruiting
• Conditions: Myocarditis
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
participant post first BNT162b2 vaccination; Patients which developed myocarditis after the first dose of BNT162b2 vaccination	Other: No intervention; This is an observational study, with no intervention.
participant post second BNT162b2 vaccination; Patients which developed myocarditis after the second dose of BNT162b2 vaccination	Other: No intervention; This is an observational study, with no intervention.
participant post third BNT162b2 vaccination; Patients which developed myocarditis after the third dose of BNT162b2 vaccination diagnosed with MIS	Other: No intervention; This is an observational study, with no intervention.
participant post COVID-19; Patients which developed myocarditis after COVID-19 infection	Other: No intervention; This is an observational study, with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess troponin levels in patients that developed acute myocarditis	troponin levels in each clinical visit will be documented	3 years
To assess PRO-BNP levels in patients that developed acute myocarditis	PRO-BNP levels in each clinical visit will be documented	3 years
To assess CRP levels in patients that developed acute myocarditis	CRP levels in each clinical visit will be documented	3 years
To assess cardiac MRI in patients that developed acute myocarditis	Cardiac MRI will be performed at least yearly and evaluated for regionally increased signal in T2-weighted images; Late gadolinium enhancement in a nonischemic pattern, Increased native T1 values on a 3T magnet.	3 years
To assess echocardiogram in patients that developed acute myocarditis	echocardiogram will be performed at least yearly and defined as normal, ST-segment elevation, with Diffuse or Non-diffuse changes, T-wave changes, Atrial fibrillation or non-sustained ventricular tachycardia.	3 years
To assess health quality by a questionnaire in patients that developed acute myocarditis	EQ-5D will be fill at least once a year. Descriptive analysis of EQ-5D profile at each observation and analysis of changes between repeated observations. Cluster analysis can be used.	3 years
To assess heart failure questionnaire in patients that developed acute myocarditis	KCCQ will be fill at least once a year.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokine in Patients after myocarditis	To assess cytokines by measuring the serum concentrations	3 years
Chemokine in Patients after myocarditis	To assess chemokines by measuring the serum concentrations	3 years
Hematopoietic Growth Factors (HGF)in patients after myocarditis	To assess Hematopoietic Growth Factors in patients with COVID-19 by measuring the To assess HGF by measuring the serum concentrations	3 years
Complement in patients after myocarditis	assess complement factors by measuring the serum concentrations	3 years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Dror Mevorach, MD, Hadassah Medical Organization

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Myocarditis
• Other Study ID Numbers: DM005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No