预防不良血管事件的流感疫苗：试点 (IVVE:Pilot)
2018年10月25日 更新者：McMaster University
流感疫苗预防不良血管事件的随机对照试验：初步研究
一项多中心、随机、安慰剂对照试验。
来自 INTER-CHF 网络的血管事件高风险参与者将被随机分配到灭活流感疫苗或安慰剂组，并在三个流感季节进行前瞻性随访。
将在流感季节之前招募 600 名参与者，并随机分配到流感疫苗或生理盐水安慰剂组。
研究概览
详细说明
心血管疾病是发病率和死亡率的主要原因。
最近有证据表明，流感引起的感染可能会引发血管事件，例如心肌梗塞和中风。
有一些证据表明接种流感疫苗可以预防此类事件，但数据尚无定论。
研究人员提出了一项随机对照试验来评估流感疫苗接种是否会预防血管疾病。
患有临床心力衰竭的成年人将被随机分配到灭活流感疫苗或生理盐水安慰剂组。
该试点研究将提供所需的数据，以确定更大规模研究的可行性。
研究类型
介入性
注册 (实际的)
107
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 年龄 ≥ 18 岁且 NYHA 功能分级 II、III 和 IV
排除标准：
- 对先前剂量的 TIV 的过敏反应
- 已知的 IgE 介导的对鸡蛋的超敏反应表现为荨麻疹、口腔和喉咙肿胀、呼吸困难、低血压或休克
- 接种流感疫苗后八周内发生吉兰-巴雷综合征
- 对新霉素的过敏反应
- 在过去三年中有两年接种过流感疫苗的患者
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：流感疫苗
发生不良血管事件的高风险参与者将接种 0.5 毫升剂量的灭活三价流感疫苗
|
0.5 毫升剂量肌肉注射
其他名称：
|
|
安慰剂比较：安慰剂疫苗接种
发生不良血管事件的高风险参与者将使用 0.5 毫升剂量的流感季节灭活的无菌盐水进行免疫。
|
0.5 毫升剂量肌肉注射
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
可行性
大体时间：六个月
|
如果不超过 5% 的所有招募受试者从一个研究组交叉到另一个研究组，并且至少有 98% 的随访。
|
六个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
不良心血管事件
大体时间：六个月
|
主要结果将是使用标准化标准的心血管死亡、非致命性心肌梗死、非致命性中风和因心力衰竭住院的复合结果。
|
六个月
|
|
心血管死亡
大体时间：六个月
|
单独的 CV 死亡将是次要结果。
|
六个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mark Loeb, MD, MSc、McMaster University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年4月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2013年9月13日
首先提交符合 QC 标准的
2013年9月13日
首次发布 (估计)
2013年9月18日
研究记录更新
最后更新发布 (实际的)
2018年10月26日
上次提交的符合 QC 标准的更新
2018年10月25日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.