Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers

A Prospective Study for Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05308680

Enrollment

336

Registered

2022-04-04

Start date

2022-01-06

Completion date

2022-03-28

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Myocardial Injury, Vaccine Adverse Reaction

Keywords

myocardial injury, vaccine, COVID-19

Brief summary

The aim of the study is to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

Detailed description

Population-based retrospective studies suggest an association between BNT162b2 (Pfizer-BioNTech) vaccination against coronavirus disease 2019 (COVID-19) and myocarditis. While the overall incidence of myocarditis is estimated to be 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher. Adult health care workers who received the BNT162b2 vaccine in two Israeli hospitals (SZMC and Shamir) during the fourth dose campaign had blood samples taken for high-sensitivity cardiac troponin (hs-cTn) measurement at the time of vaccine administration and after 2-4 days. Post-vaccine myocardial injury was defined as hs-cTn elevation above the 99th percentile upper reference limit and \>50% increase from the first measurement. Participants with evidence of myocardial injury underwent assessment for possible myocarditis including electrocardiogram and echocardiography.

Interventions

BIOLOGICALBNT162b2

Administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Adult health care workers (≥18 years old)

Exclusion criteria

* Acute coronary syndrome, peri/myocarditis, cardiac catheterization, cardiac surgery, cardiac ablation, or any other invasive cardiac procedure within 14 days prior to study enrollment. * Chronic renal failure (creatinine clearance ≤30 mL/min), or dilated or hypertrophic cardiomyopathy

Design outcomes

Primary

Measure	Time frame	Description
Myocardial Injury	2-4 days after vaccine administration	Myocardial injury was defined as high sensitivity cardiac troponin elevation above the 99th percentile upper reference limit and \>50% increase from baseline measurement

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026