Prevalence of Perimyocarditis After Covid-19 Vaccine

• Conditions: Perimyocarditis; Covid19
• Interventions: Diagnostic Test: Laboratory Blood Tests; Diagnostic Test: ECG; Diagnostic Test: PCR; Diagnostic Test: Antibody test; Diagnostic Test: Echocardiography; Diagnostic Test: MRI

• Registration Number: NCT04865900
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Status Verified: 2021-04
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Last Update Submitted: 2021-04-28
• Study First Posted: 2021-04-29
• Last Update Posted: 2021-04-29
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19

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Exclusion Criteria

• Patients infected with Covid19

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid19 Vaccinated Patients	Echocardiography	Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19
Covid19 Vaccinated Patients	Laboratory Blood Tests	Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19
Covid19 Vaccinated Patients	ECG	Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19
Covid19 Vaccinated Patients	PCR	Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19
Covid19 Vaccinated Patients	Antibody test	Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19
Covid19 Vaccinated Patients	MRI	Patients who are planning to receive Pfizer-BioNTech BNT162b2 vaccines against Covid19

Primary Outcome Measures

Name	Time	Method
Elevated Troponin	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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel