NCT01395082已完成不适用
ACAM2000® Myopericarditis Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination
研究概览
简要总结
The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.
Primary Objective:
- To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.
Other Pre-defined Objective:
- To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.
详细描述
All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service
- •Documented vaccination with ACAM2000® vaccine
- •Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis.
排除标准
- •Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.
结局指标
主要结局
The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination
时间窗: 2 years after enrollment or after the last symptoms or positive findings
次要结局
未报告次要终点
研究者
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