Prevalence of Perimyocarditis After Covid-19 Vaccine

NCT ID: NCT04865900

Last Updated: 2021-04-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-09

Study Completion Date

2022-04-30

Brief Summary

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The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19.

Detailed Description

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Conditions

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Perimyocarditis Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Covid19 Vaccinated Patients

Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19

Laboratory Blood Tests

Intervention Type DIAGNOSTIC_TEST

Blood tests to determine liver and kidney functioning, total blood count, and troponin levels

ECG

Intervention Type DIAGNOSTIC_TEST

ECG to determine heart rate and functioning

PCR

Intervention Type DIAGNOSTIC_TEST

PCR test to determine whether patient has Covid19

Antibody test

Intervention Type DIAGNOSTIC_TEST

Antibody test to determine level of antibodies to Covid19

Echocardiography

Intervention Type DIAGNOSTIC_TEST

If Troponin level elevated echocardiography to determine heart function

MRI

Intervention Type DIAGNOSTIC_TEST

If Troponin level elevated MRI to determine heart function

Interventions

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Laboratory Blood Tests

Blood tests to determine liver and kidney functioning, total blood count, and troponin levels

Intervention Type DIAGNOSTIC_TEST

ECG

ECG to determine heart rate and functioning

Intervention Type DIAGNOSTIC_TEST

PCR

PCR test to determine whether patient has Covid19

Intervention Type DIAGNOSTIC_TEST

Antibody test

Antibody test to determine level of antibodies to Covid19

Intervention Type DIAGNOSTIC_TEST

Echocardiography

If Troponin level elevated echocardiography to determine heart function

Intervention Type DIAGNOSTIC_TEST

MRI

If Troponin level elevated MRI to determine heart function

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19

Exclusion Criteria

* Patients infected with Covid19
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saif Abu-Moch, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Elisabeth Mahajna, MA

Role: CONTACT

972-4-7744695

Other Identifiers

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HYMC-0046-21

Identifier Type: -

Identifier Source: org_study_id

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