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
1 other identifier
observational
336
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2022
CompletedFirst Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedMay 9, 2022
May 1, 2022
18 days
March 31, 2022
May 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial Injury
Myocardial injury was defined as high sensitivity cardiac troponin elevation above the 99th percentile upper reference limit and \>50% increase from baseline measurement
2-4 days after vaccine administration
Interventions
Administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19
Eligibility Criteria
Adult health care workers who received the BNT162b2 vaccine (Pfizer-BioNTech) during the fourth dose campaign
You may qualify if:
- Adult health care workers (≥18 years old)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaare zedek MC
Jerusalem, Israel
Related Publications (1)
Levi N, Moravsky G, Weitsman T, Amsalem I, Bar-Sheshet Itach S, Algur N, Lapidus I, Mitz O, Glikson M, Wiener-Well Y, Hasin T. A prospective study on myocardial injury after BNT162b2 mRNA COVID-19 fourth dose vaccination in healthy persons. Eur J Heart Fail. 2023 Feb;25(2):313-318. doi: 10.1002/ejhf.2687. Epub 2022 Sep 28.
PMID: 36097844DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Heart Failure Unit, Jesselson Integrated Heart Center,
Study Record Dates
First Submitted
March 31, 2022
First Posted
April 4, 2022
Study Start
January 6, 2022
Primary Completion
January 24, 2022
Study Completion
March 28, 2022
Last Updated
May 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share