The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 210
- 试验地点
- 5
- 主要终点
- The presence of ≥1 new brain lesions on DWI
研究概览
简要总结
The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age 18 years or older
- •Ruptured brain aneurysm deemed suitable for neuroendovascular repair
- •Normal baseline brain MRI
- •Female subjects of childbearing potential have a negative pregnancy test.
- •Signed informed consent prior to entering study
排除标准
- •Dissecting or mycotic brain aneurysm.
- •Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment
- •Renal insufficiency with creatinine ≥ 265 umol/L
- •Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg)
- •Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
- •Pre-morbid modified Rankin scale score of greater than 1
- •Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations Patients who are unable to have an MRI scan for any reason.
- •Currently participating or previously participated in any investigational drug or device study within 6 months.
研究组 & 干预措施
Remote ischemic conditioning group
干预措施: remote ischemic conditioning (Device)
Sham remote ischemic conditioning group
干预措施: sham remote ischemic conditioning (Device)
结局指标
主要结局
The presence of ≥1 new brain lesions on DWI
时间窗: within 72 hours after endovascular treatment
Assessed by DWI
次要结局
- Number of new ischemic lesions(within 72 hours after endovascular treatment)
- Volume of new ischemic lesions(within 72 hours after endovascular treatment)
- National Institutes of Health Stroke Scale(7 days or discharge)
- Composite of Cerebrovascular events(30 days)
- Nondisabling events(30 days)
- Modified Rankin Scale(30 days)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University