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临床试验/NCT04967807
NCT04967807进行中(未招募)不适用

Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年8月5日最近更新:
适应症
干预措施

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

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

Other

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

Other

Those with clinical findings suggestive of myocarditis/myocardial injury after COVID-19 vaccination

干预措施: Blood Biomarkers (Diagnostic Test)

Cohort B - Asymptomatic

Other

Those without signs or symptoms suggestive of myocarditis after COVID-19 vaccination

干预措施: Cardiac PET/MRI (Diagnostic Test)

Cohort B - Asymptomatic

Other

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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