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Cerebrovascular Reactivity Measurements With High-Density Diffuse Optical Tomography (HDDOT CVR)

2026年8月17日 更新者：Washington University School of Medicine

The purpose of the study protocol is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure oxygen extraction fraction (OEF) and cerebrovascular reactivity (CVR) in participants with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to deliver carbon dioxide evenly and as safely as possible, we will use RespirACT, an MRI-compatible device, to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time. We will also use a high density diffuse optical tomography (HD-DOT) cap to assess the measurement of OEF and CVR. This study will investigate both regional OEF and CVR simultaneously to understand each marker's unique developmental trajectory and contribution to stroke risk in children. This work will expand insights into mechanisms of stroke in children and assess the feasibility of the HD-DOT cap for obtaining these insights by comparing a cohort of optical CVR and a cohort of MRI CVR.

In addition to the MRI and/or HD-DOT cap with RespirAct, participants may also have their vitals measured, complete cognitive testing, and complete a blood draw with a study visit. Participants may be followed for up to three years and may complete both an MRI scan and an HD-DOT scan within 1 week-12 months of each other. Participants may be invited back to repeat MRI and/or HD-DOT scans 1-2 times over the next three years.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The purpose of the study protocol is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure OEF and CVR in participants with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to deliver carbon dioxide evenly and as safely as possible, we will use RespirACT, an MRI-compatible device, to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time. We will also use an HD-DOT cap to assess the measurement of OEF and CVR.

研究类型

介入性

注册 (估计的)

120

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。

学习联系方式

学习地点

  • 美国
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University in St. Louis
        • 接触：
        • 首席研究员：
          • Kristin Guilliams, MD
        • 首席研究员：
          • Adam Eggebrecht

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

是的

描述

Inclusion Criteria:

  • 6-70 Years Old
  • Able to participate in MRI scan without sedation
  • May or may not have HbSS or beta thalassemia null genotypes of sickle cell anemia

Exclusion Criteria:

  • Significant craniofacial malformation or technical contraindications to DOT monitoring (for HDDOT imaging)
  • Metal in/on the body that is contraindicated for MRI safety (for MRI imaging)

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：非随机化
  • 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
有源比较器：健康对照
其他：Carbon Dioxide
Participants inhale carbon dioxide, delivered by computer-controlled delivery system, to target specific levels of carbon dioxide while in magnetic resonance imaging scan and/or during HDDOT imaging to measure cerebrovascular reactivity.
有源比较器：Sickle Cell Anemia Participants
其他：Carbon Dioxide
Participants inhale carbon dioxide, delivered by computer-controlled delivery system, to target specific levels of carbon dioxide while in magnetic resonance imaging scan and/or during HDDOT imaging to measure cerebrovascular reactivity.

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
HDDOT-Based Cerebrovascular Reactivity
大体时间：~15 minutes during the MRI scan and ~60 minutes during the HDDOT imaging.
Changes in relative concentration of deoxyhemoglobin with fluctuations of carbon dioxide as compared to gold standard measurement of MRI-based cerebrovascular reactivity.
~15 minutes during the MRI scan and ~60 minutes during the HDDOT imaging.

次要结果测量

结果测量
措施说明
大体时间
Cerebral Oxygen Metabolism
大体时间：From administration of carbon dioxide to end of inhalation of carbon dioxide -- 60 minutes during MRI and/or HDDOT imaging.
MRI-based cerebral based blood flow oxygen extraction fraction will be combined with laboratory data estimating arterial oxygen content to calculate cerebral oxygen metabolism.
From administration of carbon dioxide to end of inhalation of carbon dioxide -- 60 minutes during MRI and/or HDDOT imaging.

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

Washington University School of Medicine

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)

2025年10月1日

初级完成 (估计的)

2030年9月30日

研究完成 (估计的)

2032年9月30日

研究注册日期

首次提交

2025年9月22日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 202508036

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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