MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Recovery of cardiac function in patients with previously documented abnormal cardiac function
研究概览
简要总结
Myocarditis is inflammation of the heart muscle. Pericarditis is inflammation of the lining surrounding the heart muscle. Symptoms of these conditions can include pain in the chest and rapid or irregular heartbeat. There are many different causes for myocarditis and pericarditis including COVID-19 infection.
The MYCOVACC study will identify patients using local screening strategies, including research communications, care provider referrals, and medical record review. The retrospective component of the study will collect information about patients suffering from vaccine associated myopericarditis and COVID-19 associated myopericarditis. Consenting patients will then be prospectively followed according to standard of care protocols. The main objectives of MYCOVACC are to describe the rate of major adverse cardiovascular events, functional outcomes including quality of life, and myocardial recovery through imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for vaccine associated myocarditis/pericarditis.
- •COVID-19 vaccination within previous 42 days. AND
- •At least one cardiac symptom of suspected myocarditis/pericarditis (Appendix 5).
- •OR At least two non-specific symptoms (Appendix 5). OR In infants and young children, at least two non-specific pediatric symptoms (Appendix 5).
- •OR No symptoms, but abnormal histopathology or a combination of abnormal cardiac biomarkers with abnormal cardiac imaging (echo or MRI).
- •At least one of the following objective findings (Brighton Criteria case definitions, Appendices 1 to 5):
- •Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation.
- •Elevated myocardial biomarker (Troponin T, Troponin I, or CK-MB).
- •Cardiac MRI abnormality.
- •Echocardiographic abnormality.
- •New or worsening arrhythmia on electrocardiogram, Holter monitor, or telemetry.
- •Elevated inflammation biomarkers: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), hs-CRP, or D-Dimer.
- •Physical examination pericardial friction rub or pulsus paradoxus.
- •Pericardial fluid or inflammation by imaging (echo, MRI, or CT).
- •Enlarged heart on chest radiograph.
- •No alternative cause of presentation. e.g. infectious or autoimmune myocarditis.
- •Inclusion criteria for COVID-19 associated myocarditis/pericarditis
- •COVID-19 infection within the previous 42 days.
- •Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
- •No alternative cause of presentation.
- •Inclusion criteria alternative etiology myocarditis.
- •Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
- •No alternative cause of presentation.
排除标准
- •For prospective invitation and follow-up, inability to provide informed consent. Consent will be sought from patients or their authorised substitute decision maker.
- •Patients not fulfilling Brighton Criteria levels 1-3 will be excluded if they are level 4 (insufficient evidence for myocarditis) or Level 5 (not myocarditis) or have an alternative diagnosis such as myocardial infarction.
结局指标
主要结局
Recovery of cardiac function in patients with previously documented abnormal cardiac function
时间窗: Through study completion, an average of 3 years
Patients with Left Ventricular Ejection Fraction (LVEF)\<55% during anytime at baseline, with LVEF increase by 5% from worst baseline measurement
Depression and anxiety using validated instruments at baseline, 3 months, 12 months, and annually
时间窗: Through study completion, an average of 3 years
Depression and anxiety data: PHQ-9 and GAD-7.
Composite Major Adverse Cardiac Event (MACE) at 30 days post vaccination (preferred by cardiovascular community) and at 42 days post vaccination (preferred by vaccine monitoring investigators)
时间窗: From date of vaccination and up to 3 years
Including any of: * Death from any cause. * Ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia). * Heart block (type II or type III block). * Heart failure (national guideline criteria). * Left ventricular systolic dysfunction (left ventricular ejection fraction \[LVEF\] \<55%). * Cardiac tamponade.
Quality of life using validated instruments at baseline, 3 months, 12 months, and annually
时间窗: Through study completion, an average of 3 years
Quality of life: EQ-5D-5L questionnaire for adults or EQ-5D-Y questionnaire for children.
Physical activity using validated instruments at baseline, 3 months, 12 months, and annually
时间窗: Through study completion, an average of 3 years
Physical activity: International Activity Questionnaire.
次要结局
- Rate of atrial arrhythmias after mRNA COVID-19 vaccination?(From date of vaccination for up to three years)
- Individual components of primary composite endpoint at 30 days and 42 days post mRNA COVID-19 vaccination?(From date of vaccination for up to three years)
- Rate of recurrence of myocarditis/pericarditis after mRNA COVID-19 vaccination?(From date of vaccination for up to three years)
- Rate of all-cause and cardiovascular mortality after mRNA COVID-19 vaccination?(From date of vaccination for up to three years)
- Rate of all-cause and cardiovascular hospitalization after mRNA COVID-19 vaccination?(From date of vaccination for up to three years)
- Rate of constrictive pericarditis after mRNA COVID-19 vaccination?(From date of vaccination for up to three years)