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临床试验/NCT03869567
NCT03869567终止不适用

Cone Beam Computed Tomography Following Thrombectomy : Identification of Hemorrhage and Distinction From Contrast Accumulation Due to Blood-Brain Barrier Disruption

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Hemorrhage presence

研究概览

简要总结

Cerebral haemorrhages following reperfusion treatments involve not only rupture of the blood-brain barrier, but also direct damage to vessels related to the equipment used and secondary toxicity to thrombolytics. The rupture of the blood-brain barrier which results from ischemia / reperfusion is responsible for stagnation of the contrast product on the exams performed after thrombectomy. It is difficult to distinguish hyperdensities related to the stagnation of contrast product and Hemorrhage on a conventional scanner. The reference imaging is the double energy scanner performed at the thrombectomy outlet. But no study directly compared the results of the flat panel with the cone beam CT performed in immediate post-thrombectomy. The investigators propose a direct comparison of the cone beam CT with the dual energy CT performed at the exit of thrombectomy.

详细描述

Until December 2014, intravenous thrombolysis was the only reperfusion therapy proven to be effective within 4 hours of a cerebral infarction and several studies showed a clear functional benefit of thrombectomy in combination with thrombolysis in the first six hours of proximal arterial occlusion. Cerebral haemorrhages following reperfusion treatments involve not only rupture of the blood-brain barrier, but also direct damage to vessels related to the equipment used and secondary toxicity to thrombolytics. The rupture of the blood-brain barrier which results from ischemia / reperfusion is responsible for stagnation of the contrast product on the exams performed after thrombectomy, but it is difficult to distinguish hyperdensities related to the stagnation of contrast product and Hemorrhage on a conventional scanner. Several techniques are available to evaluate the hyperdensities post endovascular cerebral reperfusion including: the dual energy ct, the flat panel CT performed in the angiography room and the conventional scanner. The Cone beam CT is a relevant exam because it is performed in the angiography room and does not require transporting the patient who can be agitated or intubated until the scanner. The reference imaging is the double energy scanner performed at the thrombectomy outlet. Some studies have shown an excellent negative predictive value of the flat panel CT to eliminate haemorrhage in post-thrombectomy but no study directly compared the results of the flat panel with the CT performed in immediate post-thrombectomy and even less with the double energy scanner, it is therefore difficult to assert the sensitivity and exact specificity of this exam to detect and distinguish haemorrhage from contrast stagnation. The investigators propose a direct comparison of the cone beam CT with the dual energy CT performed at the exit of thrombectomy.

Method: consecutive patients presenting acute ischemic stroke candidates to thrombectomy will be enrolled in one hospital center. A cone beam Ct will be performed at the end of the procedure as well as a dual energy CT and finally a CT 24 h after the thrombectomy. Predictive factors of hemorrhage transformation such blood barrier disruption will be studied secondarily.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients with cerebral thrombectomy
  • Patients able to express consent
  • Signed written informed consent form
  • Covered by national health insurance

排除标准

  • pregnancy or beast feeding
  • patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
  • obstruction to participate
  • non covered by national health insurance

研究组 & 干预措施

Cone beam CT

Experimental

A cone beam CT wll be performed just after thrombectomy on patients with acute ischemic stroke

干预措施: cone beam CT (Device)

结局指标

主要结局

Hemorrhage presence

时间窗: up to two days

hemorrhage presence or not is determined with cone beam and scanner images

次要结局

  • Health deterioration(24 hours from symptom onset)
  • Number of patients with hemorrhagic transformation(24 hours from symptom onset)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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