Myocarditis Post Vaccination or Multi System Inflammatory Syndrome

NCT05288426 | Unknown

• 1 other identifier: DM005
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocarditis

Outcome Measures

Primary Outcomes (7)

• To assess troponin levels in patients that developed acute myocarditis

  troponin levels in each clinical visit will be documented

  3 years

• To assess PRO-BNP levels in patients that developed acute myocarditis

  PRO-BNP levels in each clinical visit will be documented

  3 years

• To assess CRP levels in patients that developed acute myocarditis

  CRP levels in each clinical visit will be documented

  3 years

• To assess cardiac MRI in patients that developed acute myocarditis

  Cardiac MRI will be performed at least yearly and evaluated for regionally increased signal in T2-weighted images; Late gadolinium enhancement in a nonischemic pattern, Increased native T1 values on a 3T magnet.

  3 years

• To assess echocardiogram in patients that developed acute myocarditis

  echocardiogram will be performed at least yearly and defined as normal, ST-segment elevation, with Diffuse or Non-diffuse changes, T-wave changes, Atrial fibrillation or non-sustained ventricular tachycardia.

  3 years

• To assess health quality by a questionnaire in patients that developed acute myocarditis

  EQ-5D will be fill at least once a year. Descriptive analysis of EQ-5D profile at each observation and analysis of changes between repeated observations. Cluster analysis can be used.

  3 years

• To assess heart failure questionnaire in patients that developed acute myocarditis

  KCCQ will be fill at least once a year.

  3 years

Secondary Outcomes (4)

• Cytokine in Patients after myocarditis

  3 years

• Chemokine in Patients after myocarditis

  3 years

• Hematopoietic Growth Factors (HGF)in patients after myocarditis

  3 years

• Complement in patients after myocarditis

  3 years

Study Arms (4)

participant post first BNT162b2 vaccination

Patients which developed myocarditis after the first dose of BNT162b2 vaccination

Other: No intervention

participant post second BNT162b2 vaccination

Patients which developed myocarditis after the second dose of BNT162b2 vaccination

Other: No intervention

participant post third BNT162b2 vaccination

Patients which developed myocarditis after the third dose of BNT162b2 vaccination diagnosed with MIS

Other: No intervention

participant post COVID-19

Patients which developed myocarditis after COVID-19 infection

Other: No intervention

Interventions

No intervention OTHER

This is an observational study, with no intervention.

participant post COVID-19; participant post first BNT162b2 vaccination; participant post second BNT162b2 vaccination; participant post third BNT162b2 vaccination

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that were hospitalized at Hadassah Medical Center and other hospitals in Israel, with the diagnosis of myocarditis post COVID-19 or post BNT162b2 vaccine (as specified in the inclusion criteria).

You may qualify if:

• 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.

You may not qualify if:

• Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from myocarditis, or otherwise suffer from valvuloplasty.
• Myocardial injury caused by sepsis, medical agents, or poisons;
• Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

RECRUITING

Related Publications (2)

• Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, Asleh R, Amir O, Meir K, Cohen D, Dichtiar R, Novick D, Hershkovitz Y, Dagan R, Leitersdorf I, Ben-Ami R, Miskin I, Saliba W, Muhsen K, Levi Y, Green MS, Keinan-Boker L, Alroy-Preis S. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 2021 Dec 2;385(23):2140-2149. doi: 10.1056/NEJMoa2109730. Epub 2021 Oct 6.

  PMID: 34614328 BACKGROUND

• Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.

  PMID: 10758967 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples obtained from patients with post vaccine (BNT162b2 vaccine ) myocarditis, or MIS following a consent.

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Dror Mevorach, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Mevorach, MD

CONTACT

972-2- 6777317; mevorachd@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Head, Department of Internal Medicine B; Head, Rheumatology Research Center, Hadassah and the Hebrew University Medical School

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: March 21, 2022
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2025
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

IL (1)