血管内手术后炎症和消退的动脉成像 (AIIRES)
2020年11月25日 更新者：University of California, San Francisco
这项研究通过使用正电子发射断层扫描-磁共振成像评估了接受外周血管介入治疗的患者的局部炎症和消退反应，例如股浅动脉 (SFA) 或腘动脉的血管成形术，或髂动脉或 SFA 的支架置入术（宠物/核磁共振成像）。
PET/MRI 将在干预前、干预后一天和一周进行。
研究概览
详细说明
磁共振成像 (MRI) 成像允许解剖结构的非侵入性可视化，而正电子发射断层扫描 (PET) 扫描允许观察分子和细胞活动。 在血管损伤后干预患者中使用 PET/MRI 有助于评估体内血管炎症和消退反应。
通过血管内干预引起的急性血管损伤会导致巨噬细胞等炎性细胞募集到血管壁。 巨噬细胞的代谢非常活跃，并且以高速率消耗葡萄糖。 在 PET/MRI 中，受试者被注射 18F-氟脱氧葡萄糖 (18F-FDG)，这是一种被巨噬细胞消耗的放射性标记的葡萄糖分子。
当 18F-FDG 被消耗时，它比其他动脉粥样硬化病变元素更热切地保留在巨噬细胞内。 因此，FDG-PET 提供了一种独特且无创的方法来定量测量干预部位的巨噬细胞活动。
这项研究将提供关键的试验数据，用于开发成像替代终点，用于未来的促解决调解治疗干预试验。
研究类型
介入性
注册 (实际的)
9
阶段
- 阶段1
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
-
-
California
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San Francisco、California、美国、94110
- San Francisco General Hospital
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San Francisco、California、美国、94143
- UCSF
-
-
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 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：
- 40岁以上，
- 休息或运动时 ABI <0.9，TBI <0.6
- 有跛行或肢体威胁性缺血并计划接受 SFA 或腘动脉的经皮血管成形术，或髂动脉或 SFA 的支架置入术。
排除标准：
- 活动性感染的证据
- 对造影剂过敏或过敏
- 慢性肝病、肾病 (GFR< 30) 或慢性炎症性疾病
- 胰岛素依赖型糖尿病
- 受试者体内、心脏起搏器或除颤器中存在金属
- BMI < 20 或 >35
- 30 天内最近的其他重大手术或疾病
- 使用免疫抑制药物或类固醇
- 器官移植史
- 怀孕，或计划怀孕，或哺乳期
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：卫生服务研究
- 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：使用 FDG-18 放射性示踪剂的 PET/MR
使用 FDG-18 放射性示踪剂，受试者接受 PET/MR 扫描，检测示踪剂的吸收情况。
|
所有受试者将在术前、术后 1 天和 1 周使用 FDG 进行 PET/MRI 扫描
|
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 |
|---|---|---|
|
在周围血管损伤前后干预部位 FDG-PET 摄取的定量测量中发现的变化。
大体时间：每周 1 次，持续 3 周
|
给予患者 18F-FDG 无线电示踪剂。
通过 FDG-PET 成像模式定量测量示踪剂在干预部位的摄取。
|
每周 1 次，持续 3 周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
周围血管损伤前后相关炎症反应和消退反应的变化。
大体时间：每周 1 次，持续 3 周
|
受试者的静脉穿刺和血液采集允许测量促炎标记物和靶向代谢脂质体。
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每周 1 次，持续 3 周
|
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：Michael S Conte, M.D.、University of California, San Francisco
- 首席研究员：Miguel H Pampaloni, M.D., PhD.、University of California, San Francisco
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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)
2017年6月1日
初级完成 (实际的)
2019年9月3日
研究完成 (实际的)
2019年9月3日
研究注册日期
首次提交
2018年5月16日
首先提交符合 QC 标准的
2018年7月16日
首次发布 (实际的)
2018年7月18日
研究记录更新
最后更新发布 (实际的)
2020年11月30日
上次提交的符合 QC 标准的更新
2020年11月25日
最后验证
2020年11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.