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Monitoring Stroke Patients With Near-infrared Spectroscopy Before, During and After Endovascular Treatment

2021年3月17日 更新者:Helle Klingenberg Iversen

Near-infrared Spectroscopy in Endovascular Treatment (Danish: Nær-infrarød Spektroskopi Ved endovaskulær Trombektomi)

The purpose of this study is to examine the hemodynamics of stroke patients with near-infrared spectroscopy before, during and after endovascular treatment and their relations to disabilities and mortality 3 months after treatment.

研究概览

详细说明

Endovascular treatment is the revascularization after ischemic stroke due to large-artery occlusion by mechanical removal of thrombi with an intraarterial catheter. The area around the infarction called the penumbra, which has partial blood supply by collateral vessels, can thereby be salvaged and the neuronal function restored. EVT lowers the disabilities and the morbidity if it is performed within 6 hours of onset or within 24 hours in stroke patients with a significant penumbra (Rodrigues, Neves et al. 2016).

However, complications can arise during EVT including critically failing CBF, intracranial hemorrhage and embolization of the thrombus to more peripheral vessels, which can all result in further brain damage.

To avoid these repercussions or detect them as fast as possible as well as detecting successful interventions, a suitable method for monitoring CBF over time is needed. NIRS is a commonly applied method that examines CBF in the cerebral cortex, which has already been used as intraoperative monitoring during abdominal and cardiac surgery (Yu, Zhang et al. 2018), but only in minor studies of EVT patients, where results have been very promising and associated to long-term outcomes (Hametner, Stanarcevic et al. 2015, Ritzenthaler, Cho et al. 2017). NIRS exploits that absorption of infrared light is only changed by hemoglobin, which can therefore by measured over time. NIRS is a non-invasive and safe method that measures oxygenated and deoxygenated hemoglobin in the cerebral cortex (Ferrari and Quaresima 2012).

Cerebral autoregulation (CA) is a complex mechanism that maintains an relatively constant and adequate CBF, which is often impaired in acute stroke patients (Paulson, Strandgaard et al. 1990). The nature of CA can be examined with NIRS (Obrig, Neufang et al. 2000, Reinhard, Wehrle-Wieland et al. 2006, Schytz, Hansson et al. 2010, Zweifel, Dias et al. 2014) and impairment can be shown (Li, Wang et al. 2010, Han, Li et al. 2014, Han, Zhang et al. 2014, Phillip and Schytz 2014). NIRS examinations of CA has never been done during EVT and the relation between changes in CA and patient outcome remains unknown.

This leads to the following hypothesis:

  • CBF and CA can be monitored with NIRS before, during and after EVT and detect complications and successful EVTs.
  • CBF and CA during and after EVT can be associated to the disabilities and mortality of stroke patients 3 months after the treatment.

The investigators will examine stroke patients who receive EVT with NIRS. The equipment will be placed on participants forehead when they arrive to the department and monitored for up to 2 hours after EVT. A 20-minute follow-up NIRS examinations will be done at 24 hours and 3 months after EVT. National Institute of Health Stroke Scale (NIHSS) will be performed before and after EVT, at 24 hours and 3 months after EVT. Participants will be assessed for functioning level and scored for independence with Modified Ranking Scale and screened for new vascular events, complications related to EVT and death by cause after 3 months.

To satisfy power calculations, 100 patients will be enrolled in the study.

研究类型

观察性的

注册 (实际的)

100

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

    • Region Hovedstaden
      • Copenhagen、Region Hovedstaden、丹麦、2100
        • Department of Neurology, Rigshospitalet

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients who could be candidates for endovascular treatment in Region Zealand and The Capital Region of Denmark are assessed in Rigshospitalet, yearly around 200 patients. If endovascular treatment is attempted, subjects will be included. Only ischemic stroke patients with large-vessel occlusion will be eligible for endovascular treatment.

Only patients fulfilling the inclusion criteria and not the exclusion criteria are eligible. Patients will be enrolled before consent is given. Consent is obtained after endovascular treatment after oral and written information is provided. Recruitment is approved by Ethics Committee.

描述

Inclusion Criteria:

  • Stroke patients receiving endovascular treatment

Exclusion Criteria:

  • Premorbid mRS > 3
  • Acute EEG examinations within 2 hours after EVT
  • Neurosurgical evacuation within 2 hours after EVT
  • Remaining life expectancy < 90 days

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

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
Oxygenated hemoglobin ratio of total hemoglobin before, during and after endovascular treatment
大体时间:From onset of examination before EVT, during EVT and up to 2 hours after EVT.
Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT
From onset of examination before EVT, during EVT and up to 2 hours after EVT.

其他结果措施

结果测量
措施说明
大体时间
Oxygenated hemoglobin ratio of total hemoglobin before and after endovascular treatment
大体时间:Baseline before EVT is initiated, last part of monitoring period (up to 2 hours) after EVT and 20 min. recordings 24 hours and 90 days after EVT.
Changes in oxygenated hemoglobin ratio of total hemoglobin from baseline (before EVT) to last part of monitoring period (up to 2 hours) and to 20 min. recordings at 24 hours and 90 days.
Baseline before EVT is initiated, last part of monitoring period (up to 2 hours) after EVT and 20 min. recordings 24 hours and 90 days after EVT.
Oxygenated hemoglobin before and after endovascular treatment
大体时间:From onset of examination before EVT, during EVT and up to 2 hours after EVT.
Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT
From onset of examination before EVT, during EVT and up to 2 hours after EVT.
Oxygenated hemoglobin before and after endovascular treatment
大体时间:Baseline before EVT is initiated, last part of monitoring period (up to 2 hours) after EVT and 20 min. recordings 24 hours and 90 days after EVT.
Changes from baseline (before EVT) to last part of monitoring period (up to 2 hours) and to 20 min. recordings at 24 hours and 90 days.
Baseline before EVT is initiated, last part of monitoring period (up to 2 hours) after EVT and 20 min. recordings 24 hours and 90 days after EVT.
Independence assessed with modified Ranking Scale (mRS)
大体时间:90 days after EVT

mRS 90 days after EVT. The mRS scale runs from 0-6, running from perfect health without symptoms (score of 0) to death (score of 6).

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
90 days after EVT
Degree of disabilities assessed by National Institute of Health Stroke Scale (NIHSS)
大体时间:Changes from just before EVT to 2 hours, 24 hours and 90 days after EVT

Changes is NIHSS from before EVT to after EVT.

National Health Institute Stroke Scale (NIHSS): Stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.

Changes from just before EVT to 2 hours, 24 hours and 90 days after EVT
Composite vascular outcome of new events
大体时间:90 days after EVT
New stroke or transitory cerebral ischemia, acute coronary syndrome or operation for peripheral artery disease.
90 days after EVT
Complications related to EVT
大体时间:90 days after EVT
Any complications related to EVT 90 days after procedure.
90 days after EVT
Mortality
大体时间:90 days after EVT
Death by cause at 90 days after EVT
90 days after EVT

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:Helle K Iversen, DMSc、Department of Neurology, Rigshospitalet

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。

一般刊物

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)

2018年11月20日

初级完成 (实际的)

2021年2月15日

研究完成 (实际的)

2021年2月15日

研究注册日期

首次提交

2018年10月17日

首先提交符合 QC 标准的

2018年11月8日

首次发布 (实际的)

2018年11月13日

研究记录更新

最后更新发布 (实际的)

2021年3月18日

上次提交的符合 QC 标准的更新

2021年3月17日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • H-18028704 (其他标识符:Scientific Ethics Committee, The Capital Region of Denmark)
  • VD-2018-269 (I-suite: 6509) (其他标识符:Danish Data Protection Agency)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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