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

S

Shaare Zedek Medical Center

Status

Completed

Conditions

COVID-19
Vaccine Adverse Reaction
Myocardial Injury

Treatments

Biological: BNT162b2

Study type

Observational

Funder types

Other

Identifiers

NCT05308680
001

Details and patient eligibility

About

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.

Full 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.

Enrollment

336 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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