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临床试验/NCT06249802
NCT06249802尚未招募4 期

Beta-blockade in Unruptured Intracranial Aneurysm

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Intracranial aneurysm growth

研究概览

简要总结

Subarachnoid haemorrhage is a devastating type of stroke, with high mortality and morbidity rate. In approximately 85% of cases, it is caused by an intracranial aneurysm rupture. Majority of patients with diagnosed intracranial aneurysm are eligible for interventional treatment, however, some patients are managed conservatively. Currently, the only recommendations for patients with conservatively managed intracranial aneurysms, are routine imaging follow-ups and minimization of rupture risk factors. There are no medications proven to decrease risk of aneurysm rupture, that might be prescribed to such patients. In preliminary study the investigators found that patients with intracranial aneurysms who took β-blockers had significantly smaller aneurysm rupture rate and dome size, as well as more favorable hemodynamic parameters. No other antihypertensive drugs showed similar associations. Therefore, in this project the investigators aim to further analyze the impact of β-blocker intake on fate of intracranial aneurysm and find possible explanations for its protective role. The investigators aim to perform a randomised, double-blind, placebo-controlled clinical trial. One hundred patients with unruptured intracranial aneurysm, , qualified to conservative management will be enrolled. Two arms (50 patients each) will be receiving nebivolol or matching placebo. Treatment in each arm will last 12 months. The following examinations will be performed at baseline and at 6 and 12 months: clinical assessment, angio-MRI with vessel wall imaging, Doppler ultrasound to extract blood flow waveforms from Internal Carotid Artery, Vertebral Artery Middle Cerebral Artery, Anterior Cerebral Artery and Posterior Cerebral Artery, as well as blood samples. Based on the results the investigators will assess changes in aneurysm size and wall contrast enhancement. The investigators will also analyze levels of possible aneurysm growth biomarkers in peripheral blood. Additionally, the investigators will prepare three-dimensional models of the artery harbouring aneurysm and perform patient-specific computer modelling of blood flow through such artery to assess hemodynamic parameters of aneurysm dome. All obtained measurements will be compared at baseline and at 6 and 12 months. The investigators hypothesize that, in comparison to the placebo group, β-blocker therapy in patients with unruptured intracranial aneurysm will contribute to favorable changes in hemodynamic parameters of aneurysm dome, decrease wall degradation process and prevent from aneurysm growth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • freshly (within 12 months) diagnosed unruptured intracranial aneurysm, non-eligible for surgical or endovascular treatment
  • age > 18 years
  • informed consent

排除标准

  • contraindications to β-blockers intake
  • previous SAH
  • intake of β-blocker currently or in the past
  • presence of other intracranial pathology
  • history of surgical or endovascular aneurysm treatment
  • contraindications for contrast-enhancement MRI examination

研究组 & 干预措施

Nebivolol arm

Experimental

Patients randomly assigned to receive active treatment with escalating doses of nebivolol.

干预措施: Nebivolol (Drug)

Placebo arm

Placebo Comparator

Patients randomly assigned to receive matching placebo tablets.

干预措施: Placebo (Drug)

结局指标

主要结局

Intracranial aneurysm growth

时间窗: 12 months

Any increase in size of intracranial aneurysm assessed by radiology specialist based on Magnetic Resonance Angiography.

Intracranial aneurysm rupture

时间窗: 12 months

Fatal or non-fatal intracranial aneurysm rupture. Outcome will be determined based on presence of subarachnoid hemorrhage on head Computer Tomography (performed in case on any symptoms).

次要结局

  • All-cause mortality(12 months)
  • Change in aneurysmal hemodynamic parameters(12 months)
  • Change in aneurysm growth biomarkers(12 months)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerzy Gąsowski

Prof.

Jagiellonian University

研究点 (1)

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