Myocarditis Clinical Trial
— MyoVaxOfficial title:
Consequences of Post BNT162b2 Vaccine Myocarditis and Multiple Inflammatory Syndrome Myocarditis
NCT number | NCT05288426 |
Other study ID # | DM005 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2021 |
Est. completion date | December 1, 2025 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 1, 2025 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess troponin levels in patients that developed acute myocarditis | troponin levels in each clinical visit will be documented | 3 years | |
Primary | To assess PRO-BNP levels in patients that developed acute myocarditis | PRO-BNP levels in each clinical visit will be documented | 3 years | |
Primary | To assess CRP levels in patients that developed acute myocarditis | CRP levels in each clinical visit will be documented | 3 years | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | To assess heart failure questionnaire in patients that developed acute myocarditis | KCCQ will be fill at least once a year. | 3 years | |
Secondary | Cytokine in Patients after myocarditis | To assess cytokines by measuring the serum concentrations | 3 years | |
Secondary | Chemokine in Patients after myocarditis | To assess chemokines by measuring the serum concentrations | 3 years | |
Secondary | Hematopoietic Growth Factors (HGF)in patients after myocarditis | To assess Hematopoietic Growth Factors in patients with COVID-19 by measuring the To assess HGF by measuring the serum concentrations | 3 years | |
Secondary | Complement in patients after myocarditis | assess complement factors by measuring the serum concentrations | 3 years |
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