Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree
研究概览
简要总结
The purpose of this study is to determine the impact of remote ischemic conditioning on dynamic cerebral autoregulation in patients with acute ischemic stroke receiving 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 experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Both groups underwent dynamic cerebral autoregulation measurements at days 1 to 2 and 7 to 10 of onset and recorded the relevant indexes, and blood samples were collected before and 24 hours after intravenous thrombolysis, we aimed to determine the impact of remote ischemic conditioning combined with intravenous thrombolysis on dynamic cerebral autoregulation in acute ischemic stroke patients. We hypothesized that remote ischemic conditioning would improve dynamic cerebral autoregulation in patients with acute ischemic stroke receiving 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
- Quadruple (Participant, Care Provider, Investigator, 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 years, < 80 years, regardless of sex;
- •Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
- •Baseline NIHSS >= 5, and <= 25;
- •Baseline GCS ≥8;
- •Signed and dated informed consent is obtained
排除标准
- •Patients who undergo endovascular treatment;
- •mRS ≥ 2 before the onset of the disease;
- •Severe organ dysfunction or failure;
- •Those who have a history of atrial fibrillation;
- •The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
- •Pregnant or lactating women;
- •Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
- •He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
- •Other conditions that the researchers think are not suitable for the group.
研究组 & 干预措施
RIC group
RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice within 6 to 24 hours from thrombolysis.
干预措施: remote ischemic conditioning (Procedure)
control group
Sham RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis.
干预措施: sham remote ischemic conditioning (Procedure)
结局指标
主要结局
Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree
时间窗: 1-2 days
A dynamic cerebral auto-regulation parameter 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 parameters.
次要结局
- Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree(7-10 days)
- Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree(7-10 days)
- Hematology related indicators(before and 24 hours after intravenous thrombolysis)
- Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree(1-2 days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University