PerimyocarditisNCT04865900
Prevalence of Perimyocarditis After Covid-19 Vaccine
An observational study of Perimyocarditis and Covid19, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Perimyocarditis, Covid19
- What is being tested?
- Laboratory Blood Tests, ECG and PCR
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Mar 2021to Apr 2022
- How long will I take part?
- 1 Week
- 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 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient Registries from local Health Maintenance Organizations
Who may be able to join
- Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19
Who cannot join
- Patients infected with Covid19
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19.
- Conditions
- Perimyocarditis, Covid19
- Being tested
- Laboratory Blood Tests, ECG, PCR, Antibody test, Echocardiography
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Blood TestsDiagnostic test
Blood tests to determine liver and kidney functioning, total blood count, and troponin levels
ECGDiagnostic test
ECG to determine heart rate and functioning
PCRDiagnostic test
PCR test to determine whether patient has Covid19
Antibody testDiagnostic test
Antibody test to determine level of antibodies to Covid19
EchocardiographyDiagnostic test
If Troponin level elevated echocardiography to determine heart function
MRIDiagnostic test
If Troponin level elevated MRI to determine heart function
| Study group | Role | What they receive |
|---|---|---|
| Covid19 Vaccinated Patients | Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19 Receives: Diagnostic Test: Laboratory Blood Tests; Diagnostic Test: ECG; Diagnostic Test: PCR; Diagnostic Test: Antibody test; Diagnostic Test: Echocardiography; Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevated Troponin
Laboratory blood tests will be taken before and after Covid19 vaccination and compared. Troponin levels above normal range of 0.4 ng/ml will indicate possibility of perimyocarditis and patient will referred for additional testing.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start9 Mar 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimyocarditisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Saif Abu-Moch, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865900
- Sponsor's protocol ID
- HYMC-0046-21
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Perimyocarditis After Covid-19 Vaccine
- ClinicalTrials.gov ID
- NCT04865900
- Acronym / sponsor ID
- HYMC-0046-21
- Conditions
- Perimyocarditis, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 29 Apr 2021 (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.
The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid19 Vaccinated Patients | – | Diagnostic Test: Laboratory Blood Tests, Diagnostic Test: ECG, Diagnostic Test: PCR, Diagnostic Test: Antibody test, Diagnostic Test: Echocardiography, Diagnostic Test: MRIPatients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19 |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient Registries from local Health Maintenance Organizations
Key inclusion criteria (1 listed)
- Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19
Key exclusion criteria (1 listed)
- Patients infected with Covid19
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 |
|---|---|---|
| Laboratory Blood TestsBlood tests to determine liver and kidney functioning, total blood count, and troponin levels | Diagnostic test | Covid19 Vaccinated Patients |
| ECGECG to determine heart rate and functioning | Diagnostic test | Covid19 Vaccinated Patients |
| PCRPCR test to determine whether patient has Covid19 | Diagnostic test | Covid19 Vaccinated Patients |
| Antibody testAntibody test to determine level of antibodies to Covid19 | Diagnostic test | Covid19 Vaccinated Patients |
| EchocardiographyIf Troponin level elevated echocardiography to determine heart function | Diagnostic test | Covid19 Vaccinated Patients |
| MRIIf Troponin level elevated MRI to determine heart function | Diagnostic test | Covid19 Vaccinated Patients |
Primary outcome
Elevated Troponin
Time frame: 4 weeks
Laboratory blood tests will be taken before and after Covid19 vaccination and compared. Troponin levels above normal range of 0.4 ng/ml will indicate possibility of perimyocarditis and patient will referred for additional testing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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.
Saif Abu-Moch, MD principal investigator
Hillel Yaffe Medical Center
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 Perimyocarditis and Covid19, run by Hillel Yaffe Medical Center 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 1 inclusion and 1 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 29 Apr 2021. 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 Elisabeth Mahajna, MA (972-4-7744695, liesma@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elevated Troponin (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2021.