Prevalence of Perimyocarditis After Covid-19 Vaccine

NCT04865900 | Unknown DMC

• 1 other identifier: HYMC-0046-21
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Study Arms (1)

Covid19 Vaccinated Patients

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

Diagnostic Test: Laboratory Blood Tests; Diagnostic Test: ECG; Diagnostic Test: PCR; Diagnostic Test: Antibody test; Diagnostic Test: Echocardiography; Diagnostic Test: MRI

Interventions

Laboratory Blood Tests DIAGNOSTIC_TEST

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

Covid19 Vaccinated Patients

ECG DIAGNOSTIC_TEST

ECG to determine heart rate and functioning

Covid19 Vaccinated Patients

PCR DIAGNOSTIC_TEST

PCR test to determine whether patient has Covid19

Covid19 Vaccinated Patients

Antibody test DIAGNOSTIC_TEST

Antibody test to determine level of antibodies to Covid19

Covid19 Vaccinated Patients

Echocardiography DIAGNOSTIC_TEST

If Troponin level elevated echocardiography to determine heart function

Covid19 Vaccinated Patients

MRI DIAGNOSTIC_TEST

If Troponin level elevated MRI to determine heart function

Covid19 Vaccinated Patients

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient Registries from local Health Maintenance Organizations

You may qualify if:

• Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19

You may not qualify if:

• Patients infected with Covid19

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Electrocardiography; Antibody Formation; Echocardiography

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Immunity, Active; Adaptive Immunity; Immunity; Immune System Phenomena; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Officials

• Saif Abu-Moch, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Mahajna, MA

CONTACT

972-4-7744695; liesma@hy.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 29, 2021
• Study Start: March 9, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

IL (1)