胸痛诊断策略的随机调查
2018年8月10日 更新者：Wake Forest University Health Sciences
临床决策单元 (CDU) 提高了资源利用率，是美国心脏病学会/美国心脏协会推荐的护理选项，但由于传统心脏检测的弱点，在非低风险胸痛患者中未得到充分利用。
心脏磁共振成像 (CMR) 对缺血具有敏感性和特异性，可同时评估心脏功能和心肌灌注，并可能彻底改变中危胸痛患者的诊断过程。
该试验的主要目的是衡量与非低风险急性胸痛患者的住院治疗相比，联合 CDU-CMR 治疗途径的效率和安全性。
研究概览
详细说明
尽管美国每年花费 120 亿美元用于胸痛的紧急评估，但只有 15% 的入院患者的症状是由心脏病引起的。 临床决策单元 (CDU) 提高了资源利用率，是美国心脏病学会/美国心脏协会推荐的护理选项，但由于传统心脏检测的弱点，在非低风险胸痛患者中未得到充分利用。 心脏磁共振成像 (CMR) 对缺血具有敏感性和特异性，可同时评估心脏功能和心肌灌注，并可能彻底改变中危胸痛患者的诊断过程。 CMR 的卓越准确性可以减少测试和侵入性操作。 对持续缺血的高灵敏度可以允许与心脏标记物并行成像。 因此，CMR 可以改善急诊科 (ED) 中度风险胸痛患者的护理。 然而，CMR 的效率和安全性尚未在 CDU 环境中得到广泛测试。
主要假设：与住院治疗策略相比，CDU-CMR 策略将减少 90 天时血运重建、再住院和反复心脏检测复合事件的发生。
方法：将从维克森林大学浸信会医学中心 (WFUBMC) ED 招募处于急性冠脉综合征 (ACS) 中等风险的参与者 (n=146) 参加临床试验。 参与者将同样随机分配到 CDU-CMR 或住院治疗。 CDU-CMR 参与者将同时接受静息和负荷 CMR 成像以及系列心脏标记物。 住院护理参与者将接受一系列心脏标记，然后进行由其护理提供者确定的现有心脏测试。 主要结果是 90 天血运重建、再住院和反复心脏检查的综合结果。 次要结果是指数住院时间。 安全事件包括出院后的 ACS、死亡率和与压力测试相关的不良事件。
研究类型
介入性
注册 (实际的)
105
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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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Baptist Medical Center
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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
21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：
- 入学时年龄大于或等于 21 岁
- 在获得用于患者评估的心电图和心脏生物标志物后，治疗医师指出的胸部不适或其他与可能的 ACS 一致的症状
- 心肌梗死溶栓 (TIMI) 风险评分 >/= 2 或医生对中等或高度可能症状的印象代表 ACS
- 患者需要住院或 CDU 对其胸痛进行评估
- 治疗医师认为如果排除心脏病，患者可以出院回家
- 主治医师认为患者可以安全接受 CDU 护理
预测试概率评估 对发展为 ACS 的中间风险的评估将基于 TIMI 风险评分 >/= 2 和/或委员会认证/委员会合格的急诊医师对症状代表 ACS 的可能性为中度或高度的临床印象。 鼓励医生使用 2007 年美国心脏病学会 (ACC)/美国心脏协会 (AHA) 指南作为该评估的框架。
排除标准：
- 升高的心脏生物标志物
- 任何心电图上的新 ST 段抬高 (>/= 1 mV)
- 任何心电图上的新 ST 段压低 (>/= 2 mV)
- 已知可诱导的心肌缺血，无需随后的血运重建
- 不能平躺
- 入组时有症状的低血压（收缩压 < 90 mm Hg）
- MRI 的禁忌症（例如：心脏起搏器、除颤器、脑动脉瘤夹、眼部金属异物、植入装置、严重的幽闭恐惧症）
- 患者拒绝或无法遵守病历审查和跟进
- 预期寿命不足 3 个月的终末诊断
- 目前怀孕
- 入组时肌酐清除率 < 45 ml/min 或临床关注急性肾损伤
- 入组时肌酐清除率 <60 毫升/分钟的慢性肝病
- 肝肾综合征
- 肝脏、心脏或肾脏移植史
- 在过去 6 个月内确认的血管成形术、支架置入术或冠状动脉旁路移植术 (CABG)
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：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：住院治疗
这是比较臂。
患者入院并接受常规护理。
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实验性的：CDU-CMR协议
患者将被转移到临床决策单元并接受负荷心脏 MRI 评估。
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在 ED 评估后，患者被随机分配到临床决策单元治疗或住院治疗。
临床决策单元的患者还将接受负荷心脏 MRI。
住院治疗组中的患者可能会接受任何所需的测试，包括由其主治医师确定的心脏 MRI。
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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90 天内血运重建、再住院和反复心脏检测的综合。
大体时间：90 天内的住院指数
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90 天内的住院指数
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次要结果测量
结果测量 |
大体时间 |
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停留时间
大体时间：指数住院时间，平均1-2天
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指数住院时间，平均1-2天
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急性冠状动脉综合征
大体时间：90 天内出院指数
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90 天内出院指数
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死亡
大体时间：90 天内的住院指数
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90 天内的住院指数
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压力测试相关的不良事件
大体时间：90 天内的住院指数
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90 天内的住院指数
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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。
调查人员
- 首席研究员：Chadwick Miller, M.D.、WFUBMC
出版物和有用的链接
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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
2010年1月1日
初级完成 (实际的)
2011年10月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2009年12月17日
首先提交符合 QC 标准的
2009年12月17日
首次发布 (估计)
2009年12月18日
研究记录更新
最后更新发布 (实际的)
2018年9月10日
上次提交的符合 QC 标准的更新
2018年8月10日
最后验证
2018年8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.