Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cerebral autoregulation parameter
研究概览
简要总结
The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis
详细描述
In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The RIC group receive basic treatment and remote ischemic conditioning for 200mmHg at 6 and 18-24 hours after intravenous thrombolysis. The sham-RIC group receive basic treatment and remote ischemic conditioning for 60mmHg at 6 and 18-24 hours after intravenous thrombolysis. Both groups underwent cerebral hemodynamics after RIC and recorded the relevant indexes. The investigators aimed to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 and < 80 years, both sexes;
- •a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-PA (0.9 mg/kg) IVT within 4.5 h of stroke onset;
- •pre-onset modified Rankin Scale (mRS) score ≤1;
- •baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;
- •Glasgow Coma Scale score ≥8.
排除标准
- •having received bridging therapy (IVT plus mechanical thrombectomy);
- •previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation;
- •contraindications to RIC treatment or previous RIC treatment or similar treatment;
- •pregnancy or breastfeeding;
- •life expectancy of ≤3 months or inability to complete the study for other reasons;
- •unwillingness to be followed up or poor treatment compliance or participation in other clinical studies;
- •had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.
结局指标
主要结局
Cerebral autoregulation parameter
时间窗: 1-10 days
Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.
次要结局
未报告次要终点
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University