Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke(RICCH-IS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cerebral autoregulation at 7 days
研究概览
简要总结
The purpose of this study is to determine the impact of remote ischemic conditioning on cerebral hemodynamics in patients with ischemic stroke.
详细描述
Current studies have shown that remote ischemic conditioning can activate neuronal signals and humoral factors, increase cerebral perfusion and promote neurological recovery in patients with ischemic stroke.The purpose of this study was to investigate the effect of remote ischemic conditioning on cerebral hemodynamics in patients with acute ischemic stroke.
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 years, <80 years, both sex;
- •Patients with a clinically definite diagnosis of acute ischemic stroke who are able to commence RIC treatment within 72 hours of stroke onset;
- •Baseline National Institute of Health Stroke Scale (NIHSS) score<25;
- •Pre-onset modified Rankin Scale (mRS) score ≤ 1;
- •Glasgow Coma Scale score ≥8;
- •Signed and dated informed consent is obtained.
排除标准
- •Patients who have undergone thrombolytic therapy or endovascular therapy;
- •Inability to cooperate sufficiently to complete the cerebral autoregulation examination (e.g., due to a condition such as agitation, drowsiness, arrhythmia, insufficient bilateral temporal bone windows, etc.) during the recording;
- •Presence of other intracranial lesions, such as cerebrovascular malformations, cerebral venous thrombosis, tumors, and other brain lesions;
- •severe hepatic and renal dysfunction or failure;
- •Patients with hematological disease, abnormal coagulation function, bleeding tendency, and platelet <100×10^9/L;
- •Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities, arterial occlusive disease, subclavian artery stenosis ≥ 50%, or subclavian steal syndrome;
- •pregnant or lactating women;
- •Previous RIC treatment or similar treatment;
- •Patients with a life expectancy of less than 3 months or patients who are unable to complete the study for other reasons;
- •unwillingness to be followed up or poor treatment adherence;
- •Individuals who are participating in other clinical studies, have participated in other clinical studies within 3 months prior to enrollment, or have participated in this research;
- •Other conditions that the investigator considers inappropriate for enrollment.
研究组 & 干预措施
RIC
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days.
干预措施: Remote ischemic conditioning (Procedure)
Sham RIC
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days.
干预措施: Sham remote ischemic conditioning (Procedure)
结局指标
主要结局
Cerebral autoregulation at 7 days
时间窗: 0 - 7 days
Difference in Cerebral autoregulation at 7 days after RIC/sham-RIC between two groups. Phase difference (PD) in degree can therefore serve as a useful tool in the evaluation of cerebral autoregulation. Continuous cerebral blood flow velocities (CBFV) in cm/s of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure (ABP) in mmHg will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Data on CBFV and ABP were processed using MATLAB using scripts developed by the research team. PD was then derived from transfer function analysis to assess the dynamic association between CBFV and ABP.
次要结局
未报告次要终点
研究者
Yi Yang
Vice President of The First Hospital of Jilin University
The First Hospital of Jilin University