MyocarditisMyoVaxNCT05288426
Myocarditis Post Vaccination or Multi System Inflammatory Syndrome
An observational study of Myocarditis, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocarditis
- Type of treatment
- Vaccines
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2021to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, 91120
dror mevorach, MD, 972-2- 6777317, mevorachd@hadassah.org.il
Dror Mevorach, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocarditis
- Being tested
- No intervention
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study, with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| participant post first BNT162b2 vaccination | Patients which developed myocarditis after the first dose of BNT162b2 vaccination Receives: Other: No intervention | |
| participant post second BNT162b2 vaccination | Patients which developed myocarditis after the second dose of BNT162b2 vaccination Receives: Other: No intervention | |
| participant post third BNT162b2 vaccination | Patients which developed myocarditis after the third dose of BNT162b2 vaccination diagnosed with MIS Receives: Other: No intervention | |
| participant post COVID-19 | Patients which developed myocarditis after COVID-19 infection Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess troponin levels in patients that developed acute myocarditis
troponin levels in each clinical visit will be documented
Measured: 3 years
To assess PRO-BNP levels in patients that developed acute myocarditis
PRO-BNP levels in each clinical visit will be documented
Measured: 3 years
To assess CRP levels in patients that developed acute myocarditis
CRP levels in each clinical visit will be documented
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
To assess heart failure questionnaire in patients that developed acute myocarditis
KCCQ will be fill at least once a year.
Measured: 3 years
Secondary outcomes (4)
Cytokine in Patients after myocarditis
To assess cytokines by measuring the serum concentrations
Measured: 3 years
Chemokine in Patients after myocarditis
To assess chemokines by measuring the serum concentrations
Measured: 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
Measured: 3 years
Complement in patients after myocarditis
assess complement factors by measuring the serum concentrations
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Nov 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mevorach Dror, Hadassah Medical Organization
- Investigators
- Dror Mevorach, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288426
- Sponsor's protocol ID
- DM005
- Acronym
- MyoVax
- Status last verified
- Mar 2022
- First submitted
- 13 Dec 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34614328Green 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.
PubMed 10758967
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Post BNT162b2 Vaccine Myocarditis and Multiple Inflammatory Syndrome Myocarditis
- ClinicalTrials.gov ID
- NCT05288426
- Acronym / sponsor ID
- MyoVax / DM005
- Conditions
- Myocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| participant post first BNT162b2 vaccination | – | Other: No interventionPatients which developed myocarditis after the first dose of BNT162b2 vaccination |
| participant post second BNT162b2 vaccination | – | Other: No interventionPatients which developed myocarditis after the second dose of BNT162b2 vaccination |
| participant post third BNT162b2 vaccination | – | Other: No interventionPatients which developed myocarditis after the third dose of BNT162b2 vaccination diagnosed with MIS |
| participant post COVID-19 | – | Other: No interventionPatients which developed myocarditis after COVID-19 infection |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- Adult males and females.
- Minors male and female.
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study, with no intervention. | Other | participant post COVID-19, participant post first BNT162b2 vaccination, participant post second BNT162b2 vaccination, participant post third BNT162b2 vaccination |
Primary outcome
To assess troponin levels in patients that developed acute myocarditis
Time frame: 3 years
troponin levels in each clinical visit will be documented
To assess PRO-BNP levels in patients that developed acute myocarditis
Time frame: 3 years
PRO-BNP levels in each clinical visit will be documented
To assess CRP levels in patients that developed acute myocarditis
Time frame: 3 years
CRP levels in each clinical visit will be documented
To assess cardiac MRI in patients that developed acute myocarditis
Time frame: 3 years
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.
To assess echocardiogram in patients that developed acute myocarditis
Time frame: 3 years
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.
To assess health quality by a questionnaire in patients that developed acute myocarditis
Time frame: 3 years
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.
To assess heart failure questionnaire in patients that developed acute myocarditis
Time frame: 3 years
KCCQ will be fill at least once a year.
4 secondary outcomes
Cytokine in Patients after myocarditis
Time frame: 3 years
Chemokine in Patients after myocarditis
Time frame: 3 years
Hematopoietic Growth Factors (HGF)in patients after myocarditis
Time frame: 3 years
Complement in patients after myocarditis
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Background: PubMed 34614328Mevorach 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.
- Background: PubMed 10758967Green 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Mevorach, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dror Mevorach, MD (972-2- 6777317, mevorachd@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess troponin levels in patients that developed acute myocarditis (time frame: 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288426, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022; AzTrials last refreshed its copy on 1 Nov 2026.