COPD 患者的外周内皮功能 (endothBPCO)
2018年10月1日 更新者：Hopital Foch
COPD（慢性阻塞性肺病）外周内皮功能障碍的评估
该研究的目的是评估成人 COPD（慢性阻塞性肺疾病）患者的外周内皮功能以及外周内皮功能与肺功能之间的关系。
研究概览
详细说明
主要标准是外周内皮功能，将通过测量流量介导的扩张（反应性充血-外周动脉张力指数）来评估。
肺功能将通过 FEV1（一秒钟用力呼气容积）、用力肺活量 (FVC) 和 25% 至 75% 之间的呼气流量 (FEF25-75%) 的测量值进行评估。
将分析这些肺功能参数与外周内皮功能之间的关系。
此外，外周内皮功能与 COPD 严重程度（根据 GOLD（慢性阻塞性肺病全球倡议）2010 年和 GOLD 2011 以及 COPD 评估测试进行分类）、心血管危险因素（SCORE INdex）和吸烟者状况之间的关系也会被评估。
研究类型
介入性
注册 (实际的)
137
阶段
- 不适用
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。
学习地点
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Paris、法国、75012
- Hôpital Saint-Antoine
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Suresnes、法国、92150
- Hôpital Foch
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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
40年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准：
- 慢性阻塞性肺病：FEV1/FVC < 70%
- 吸烟者或戒烟者（≥ 10 包年）
- 最近三个月没有 COPD 恶化
- 无哮喘病史，无呼吸道过敏史
排除标准：
- 孕妇或哺乳期妇女
- 肺血管扩张剂治疗
- 患有严重急性疾病的患者。 重大疾病定义为研究者认为可能影响试验结果的疾病。
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：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：慢性阻塞性肺病患者
使用 EndoPAT® 测量 COPD 患者的内皮功能
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使用特定设备 (EndoPAT®) 通过反应性充血-外周动脉张力指数测量外周内皮功能
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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 |
|---|---|---|
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反应性充血-外周动脉张力指数的测量
大体时间：第一天
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反应性充血-外周动脉张力指数的测量
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第一天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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一秒钟内用力呼气流量的测量
大体时间：第一天
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一秒钟内用力呼气流量的测量
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第一天
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用力肺活量测量
大体时间：第一天
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用力肺活量测量
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第一天
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测量呼气流量在 25% 和 75% 之间 (FEF25-75%)。
大体时间：第一天
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测量呼气流量在 25% 和 75% 之间 (FEF25-75%)。
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第一天
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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。
赞助
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。
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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 (实际的)
2012年12月17日
初级完成 (实际的)
2017年7月6日
研究完成 (实际的)
2017年8月17日
研究注册日期
首次提交
2015年10月16日
首先提交符合 QC 标准的
2015年10月30日
首次发布 (估计)
2015年11月1日
研究记录更新
最后更新发布 (实际的)
2018年10月3日
上次提交的符合 QC 标准的更新
2018年10月1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.