Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Prevalence of myocardial inflammation on PET/MRI
研究概览
简要总结
The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.
详细描述
Coronavirus disease 2019 (COVID-19) vaccination frequently leads to minor side effects that may be more intense after the second dose, including fatigue and pain. However, there are emerging reports of more serious side effects in a minority of patients including myocarditis. Given the recent introduction of COVID-19 vaccination, there is limited understanding of: (i) prevalence and pattern of myocardial injury post vaccination, (ii) the risk factors for myocardial injury and adverse cardiac events post vaccination, and (iii) imaging and blood biomarkers for early recognition of patients at risk of adverse outcomes.
This study will address the above-mentioned knowledge gaps by focusing on patients who have received at least one dose of a COVID-19 vaccine. The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 17 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 17 years (both Cohort A and B)
- •Received at least one dose of a COVID-19 vaccine in the past 6 months (both Cohort A and B)
- •Developed new clinical signs or symptoms suggestive of myocarditis/myocardial injury within one month of COVID vaccine administration without other known cause (Cohort A, only)
排除标准
- •Contraindications to cardiac PET/MRI
- •Current history of COVID-19
研究组 & 干预措施
Cohort A - Symptomatic
Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination
干预措施: Cardiac PET/MRI (Diagnostic Test)
Cohort A - Symptomatic
Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination
干预措施: Blood Biomarkers (Diagnostic Test)
Cohort B - Asymptomatic
Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination
干预措施: Cardiac PET/MRI (Diagnostic Test)
Cohort B - Asymptomatic
Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination
干预措施: Blood Biomarkers (Diagnostic Test)
结局指标
主要结局
Prevalence of myocardial inflammation on PET/MRI
时间窗: 6months and 12months
The prevalence of myocardial inflammation on PET/MRI will be compared between symptomatic and asymptomatic patients
次要结局
- Myocardial edema(6months and 12months)
- Major adverse cardiac events (MACE)(6months and 12months)
- Left ventricular dysfunction(6months and 12months)
