Consequences of Post BNT162b2 Vaccine Myocarditis and Multiple Inflammatory Syndrome Myocarditis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To assess troponin levels in patients that developed acute myocarditis
研究概览
简要总结
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.
详细描述
Aim of Study
The primary aim of the study is to evaluate the impact of long term impact of myocarditis which has been developed secondary to Covid 19 vaccine or Covid 19 infection.
The primary end points of the study will be functional evaluations of the patients using clinical evaluation that includes questionnaires, ECG findings, evaluation of the systolic and diastolic function of the heart using echocardiogram or cardiac MRI, laboratory tests including troponin, CPK, CRP, Pro-BNP, and cytokines/chemokines.
Methods In this prospective study patients will be recruited from health care providers The selected patients will come to Hadassah hospital within 6 and 12 months after they have been diagnosed with myocarditis. Upon the patients arrival they will sign the informed consent, the investigators will draw blood tests and the participants will perform an echocardiogram according to the special protocol and will perform cardiac- MRI according to the myocarditis protocol. Patients will fulfill health questionnaires. that may include 36 Health Survey Questionnaire (SF-36); Scores on the European Quality of Life-5 Dimensions (EQ-5D) survey, which is also health-related quality of life score; the Scores on the European Quality of Life Visual Analogue Scale (EQ-VAS); Kansas City Cardiomyopathy Questionnaire (KCCQ). the Investigators will obtain blood samples from all the patients: complete blood count, c- reactive protein, troponin, CPK, Pro-BNP, liver and kidney functions, magnesium and cytokines. In addition, all participants will undergo echocardiogram test to evaluate their systolic and diastolic function of the heart.
Ethical Considerations
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
To assess troponin levels in patients that developed acute myocarditis
时间窗: 3 years
troponin levels in each clinical visit will be documented
To assess PRO-BNP levels in patients that developed acute myocarditis
时间窗: 3 years
PRO-BNP levels in each clinical visit will be documented
To assess CRP levels in patients that developed acute myocarditis
时间窗: 3 years
CRP levels in each clinical visit will be documented
To assess cardiac MRI in patients that developed acute myocarditis
时间窗: 3 years
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.
To assess echocardiogram in patients that developed acute myocarditis
时间窗: 3 years
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.
To assess health quality by a questionnaire in patients that developed acute myocarditis
时间窗: 3 years
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.
To assess heart failure questionnaire in patients that developed acute myocarditis
时间窗: 3 years
KCCQ will be fill at least once a year.
次要结局
- Chemokine in Patients after myocarditis(3 years)
- Complement in patients after myocarditis(3 years)
- Cytokine in Patients after myocarditis(3 years)
- Hematopoietic Growth Factors (HGF)in patients after myocarditis(3 years)
研究者
Mevorach Dror
Professor & Head, Department of Internal Medicine B; Head, Rheumatology Research Center, Hadassah and the Hebrew University Medical School
Hadassah Medical Organization