使用 MRI 的无辐射心导管术
2024年2月5日 更新者：Joshua Kanter
目前，心脏导管插入术中使用的导管通过 X 射线拍摄的照片引导穿过心腔和血管。
该技术使患者暴露于辐射中。
通过这项研究协议，研究人员将使用 MRI 技术拍摄实时照片，以在整个心腔内导航导管。
MRI 使用电磁能；因此，它不会使参与者暴露于辐射能量中。
研究概览
详细说明
参与者接受全身麻醉，并在 X 射线导管插入术实验室获得血管通路。
接下来，参与者被转移到 MRI 扫描仪中，在那里进行集中的 MRI 检查。
然后使用实时 MRI 引导将导管导入心腔，以执行常规的心导管插入术步骤。
如果时间允许，在参与者返回 X 射线导管插入术实验室之前进行额外的研究 MRI。
如果任何 MRI 引导导管插入术步骤不成功，则在参与者使用常规 X 射线引导图片返回 X 射线导管插入术实验室后执行临床指示的步骤。
研究类型
介入性
注册 (估计的)
50
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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District of Columbia
-
Washington、District of Columbia、美国、20010
- Children's National Health System
-
-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 接受医学上必要的心血管导管插入术
排除标准：
- 心血管不稳定，包括血流动力学不稳定（例如需要显着的血管活性输注支持）或机械血流动力学支持。
- 怀孕的妇女
- 正在哺乳且 24 小时内不打算丢弃母乳的女性
有 MRI 扫描禁忌症的患者将被排除在外。 这些禁忌症包括使用以下设备的患者：
- 中枢神经系统动脉瘤夹
- 植入式神经刺激器
- 根据制造商的说法，植入式心脏起搏器或除颤器不是 MR 安全的或 MR 有条件的
- 人工耳蜗
- 眼部异物（例如 金属屑）
- 植入式胰岛素泵
- 金属弹片或子弹
钆（造影剂）的排除标准
1.估计肾小球滤过率<30 ml/min/1.73的肾脏疾病 m2体表面积
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：诊断
- 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 |
|---|---|
|
实验性的：MRI引导下心导管检查
磁共振成像将用于指导心导管插入术。
|
磁共振成像将尽可能用于指导心导管插入手术，以避免或尽量减少 X 射线辐射暴露。
|
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 |
|---|---|---|
|
使用实时 MRI 测试将导管导航到右心结构的可行性
大体时间：在每次导管插入术结束时直至研究完成，最多 5 年。
|
心脏导管插入术通常使用 X 射线引导。
使用市售的 MRI 兼容导管，将使用实时磁共振成像 (MRI) 完成右心导管插入术。
MRI 引导不使用 X 射线辐射。
|
在每次导管插入术结束时直至研究完成，最多 5 年。
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
过早终止 MRI 心导管插入术的参与者人数
大体时间：通过研究完成每次导管插入术结束时，最多 5 年
|
在下列情况下会提前终止：
|
通过研究完成每次导管插入术结束时，最多 5 年
|
|
辐射暴露的测量
大体时间：学业结束，5年。
|
将这组受试者的辐射暴露与在 CNMC 接受匹配的有创心脏病学手术的历史对照进行比较。
|
学业结束，5年。
|
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：Joshua Kanter, MD、Children's National Research Institute
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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- Ratnayaka K, Kanter JP, Faranesh AZ, Grant EK, Olivieri LJ, Cross RR, Cronin IF, Hamann KS, Campbell-Washburn AE, O'Brien KJ, Rogers T, Hansen MS, Lederman RJ. Radiation-free CMR diagnostic heart catheterization in children. J Cardiovasc Magn Reson. 2017 Sep 6;19(1):65. doi: 10.1186/s12968-017-0374-2.
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3月1日
初级完成 (估计的)
2024年12月1日
研究完成 (估计的)
2024年12月1日
研究注册日期
首次提交
2016年2月17日
首先提交符合 QC 标准的
2016年4月13日
首次发布 (估计的)
2016年4月14日
研究记录更新
最后更新发布 (实际的)
2024年2月6日
上次提交的符合 QC 标准的更新
2024年2月5日
最后验证
2024年2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.