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Prevalence of Perimyocarditis After Covid-19 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04865900
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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

Condition or disease Intervention/treatment
Perimyocarditis Covid19 Diagnostic Test: Laboratory Blood Tests Diagnostic Test: ECG Diagnostic Test: PCR Diagnostic Test: Antibody test Diagnostic Test: Echocardiography Diagnostic Test: MRI

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Prevalence of Perimyocarditis After Covid-19 Vaccine
Actual Study Start Date : March 9, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient Registries from local Health Maintenance Organizations
Criteria

Inclusion Criteria:

  • Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19

Exclusion Criteria:

  • Patients infected with Covid19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865900


Contacts
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Contact: Elisabeth Mahajna, MA 972-4-7744695 liesma@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Saif Abu-Moch, MD Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT04865900    
Other Study ID Numbers: HYMC-0046-21
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs