Myocarditis Post Vaccination or Multi System Inflammatory Syndrome
NCT ID: NCT05288426
Last Updated: 2022-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2021-11-01
2025-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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participant post first BNT162b2 vaccination
Patients which developed myocarditis after the first dose of BNT162b2 vaccination
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
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
No intervention
This is an observational study, with no intervention.
participant post COVID-19
Patients which developed myocarditis after COVID-19 infection
No intervention
This is an observational study, with no intervention.
Interventions
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No intervention
This is an observational study, with no intervention.
Eligibility Criteria
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Inclusion Criteria
* 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
* Myocardial injury caused by sepsis, medical agents, or poisons;
* Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study
16 Years
ALL
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Mevorach Dror
Professor & Head, Department of Internal Medicine B; Head, Rheumatology Research Center, Hadassah and the Hebrew University Medical School
Principal Investigators
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Dror Mevorach, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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DM005
Identifier Type: -
Identifier Source: org_study_id
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