NCT05451030已完成不适用
The Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT): A Prospective, Randomized Controlled, Blind Outcome Evaluation, Multi-center Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2022年6月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Changes in cerebral circulation time
研究概览
简要总结
Cerebral circulation time in patients with severe carotid artery stenosis was found to be associated with hyperperfusion syndrome. Remote ischemic preconditioning can change the ability of cerebral autoregulation. The prospective, randomized controlled, blind outcome evaluation, multi-center study aimed to investigate the effect of remote ischemic preconditioning on cerebral circulation time in patients with severe carotid artery stenosis.
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
- Single (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, regardless of gender;
- •patients with severe carotid stenosis eligible for stenting (70-99% stenosis confirmed by DSA);
- •non-responsible vessel stenosis <50% if bilateral carotid stenosis or combined posterior circulation stenosis is present;
- •first DSA suggestive of ≥ 0.8 seconds difference (CCT on the affected side - CCT on the healthy side);
- •baseline modified Rankin Scale (mRS) ≤ 2 points.
- •signed the informed consent form.
排除标准
- •baseline mRS ≥ 3 points;
- •severe long-segment calcification of the carotid artery, severe distortion of aortic arch branches, anatomical variation of the aortic arch, and etc, which are not suitable for stenting
- •spontaneous intracranial hemorrhage within 12 months;
- •previous severe stroke or myocardial infarction within 3 months;
- •active bleeding and coagulation disorders, which is contraindication to heparin and antiplatelet agents;
- •a large intracranial aneurysm that cannot be treated simultaneously;
- •severe insufficiency of vital organs such as the heart, lungs, liver and kidneys, or malignant tumors with an expected survival cycle of less than six months;
- •total occlusion of carotid artery without obvious cerebral ischemic symptoms
- •unable to tolerate anesthesia;
- •severe dementia;
- •uncontrolled hypertension ;
- •allergy to contrast media;
- •pregnancy;
- •being involved in studies with other drugs or instruments, etc;
- •contraindications to remote ischemic preconditioning, such as those with more severe soft tissue injuries, fractures or vascular injuries in the upper extremity, or peripheral vascular lesions in the distal upper extremity.
结局指标
主要结局
Changes in cerebral circulation time
时间窗: pre-intervention
次要结局
- changes in collateral scoring based on digital subtraction angiography(pre-intervention)
- occurence of hyperperfusion syndrome after carotid artery stenting(24 hours and 7 days after carotid artery stenting)
- changes in contrast staining on brain computerized tomography after carotid artery stenting(1 hours and 24 hours after carotid artery stenting)
研究者
Hui-Sheng Chen
Head of Neurology
General Hospital of Shenyang Military Region
研究点 (1)
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