Prevalence of Perimyocarditis After Covid-19 Vaccine

April 28, 2021 updated by: Hillel Yaffe Medical Center
The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Recruiting
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient Registries from local Health Maintenance Organizations

Description

Inclusion Criteria:

  • Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19

Exclusion Criteria:

  • Patients infected with Covid19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid19 Vaccinated Patients
Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19
Diagnostic test: Laboratory Blood Tests
Blood tests to determine liver and kidney functioning, total blood count, and troponin levels
Diagnostic test: ECG
ECG to determine heart rate and functioning
Diagnostic test: PCR
PCR test to determine whether patient has Covid19
Diagnostic test: Antibody test
Antibody test to determine level of antibodies to Covid19
Diagnostic test: Echocardiography
If Troponin level elevated echocardiography to determine heart function
Diagnostic test: MRI
If Troponin level elevated MRI to determine heart function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Saif Abu-Moch, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-0046-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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