Consequences of Post BNT162b2 Vaccine Myocarditis and Multiple Inflammatory Syndrome Myocarditis

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

BNT162b2 vaccine has become one of the most prevalent vaccines against the COVID-19 and is currently the main vaccine used in Israel. Since marketing and the beginning of use of the vaccine, we and others have reported. of the development of post vaccination myocarditis. In this study the investigators wish to explore the long term impact on 150 patients who have been diagnosed with myocarditis or multisystem inflammatory syndrome (MIS) in the year following their diagnosis of Myocarditis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

• Adult males and females.

• Minors male and female.

⁃ Diagnosed as myocarditis:

• Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP)

• Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;

• Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) \< 45%, or by cardiac magnetic resonance imaging.

Locations
Other Locations
Israel
Hadassah Medical Center
RECRUITING
Jerusalem
Contact Information
Primary
Dror Mevorach, MD
mevorachd@hadassah.org.il
972-2- 6777317
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 150
Treatments
participant post first BNT162b2 vaccination
Patients which developed myocarditis after the first dose of BNT162b2 vaccination
participant post second BNT162b2 vaccination
Patients which developed myocarditis after the second dose of BNT162b2 vaccination
participant post third BNT162b2 vaccination
Patients which developed myocarditis after the third dose of BNT162b2 vaccination diagnosed with MIS
participant post COVID-19
Patients which developed myocarditis after COVID-19 infection
Related Therapeutic Areas
Sponsors
Leads: Hadassah Medical Organization

This content was sourced from clinicaltrials.gov