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

Sponsor

Shaare Zedek Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT05308680

Collaborator

(none)

336

Enrollment

Location

2.7

Actual Duration (Months)

126.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Injury Vaccine Adverse Reaction COVID-19	Biological: BNT162b2

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.

Study Design

Study Type:

Observational

Actual Enrollment :

336 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 6, 2022

Actual Primary Completion Date :

Jan 24, 2022

Actual Study Completion Date :

Mar 28, 2022

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaare zedek MC	Jerusalem		Israel

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tal Hasin, Head of Heart Failure Unit, Jesselson Integrated Heart Center,, Shaare Zedek Medical Center

ClinicalTrials.gov Identifier:

NCT05308680

Other Study ID Numbers:

First Posted:

Apr 4, 2022

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Tal Hasin, Head of Heart Failure Unit, Jesselson Integrated Heart Center,, Shaare Zedek Medical Center

myocardial injury

vaccine

COVID-19

Additional relevant MeSH terms:

COVID-19

Wounds and Injuries

Study Results

No Results Posted as of May 9, 2022