跳至主要内容
临床试验/NCT05860946
NCT05860946尚未招募不适用

Safety and Efficacy of Remote Ischemic Conditioning in Adult Moyamoya Disease Patients Undergoing Revascularization Surgery

Huashan Hospital0 个研究点目标入组 44 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
主要终点
the incidence of major neurologic complications during perioperative period

研究概览

简要总结

Remote ischemic conditioning (RIC) is a non-invasive therapeutic approach for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. Many protective factors produced by the stimulus of RIC could protect remote target organs and tissues through inhibiting oxidation and inflammation. The phenomenon of this protect effect was first found in myocardium ischemia-reperfusion injury and then RIC was used in children cardiac surgery to provide myocardial protection during operation. Then RIC was gradually applied to brain protection and a series of clinical researches have confirmed that it could improve the cerebral perfusion status, increase cerebral tolerance to ischemic injury, reduce perihematomal edema and promote clearance. Recently, a randomized controlled study reported that daily RIC could improve cerebral perfusion and slow arterial progression of adult MMD. Meanwhile, a single-arm open-label study also indicated that RIC was a promising noninvasive method for ischemic MMD control by relieving symptoms and reducing stroke recurrence. In addition, the effects of RIC on reducing neurological complications in MMD patients treated with revascularization surgery has also been reported. However, the mechanism of RIC in reducing peri-operative complications for MMD patients is still unknown. Thus, we conducted a randomized controlled study to explore the safety and efficacy of RIC in adult MMD patients undergoing revascularization therapy

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 18 to 65 years old;
  • Subjects all performed digital subtraction angiography (DSA) and diagnosed with MMD accroding to the criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Wills) of the Ministry of Health and Welfare of Japan in
  • Modified Rankin Scale (mRS) score<4;
  • Informed consent obtained from the patient or legally authorized representative.

排除标准

  • Subjects suffered from acute ischemic or hemorrhagic stroke within 3 months;
  • Severe hepatic or renal dysfunction;
  • Severe cardiac disease;
  • Severe hemostatic disorder or severe coagulation dysfunction;
  • Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year;
  • Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy;

结局指标

主要结局

the incidence of major neurologic complications during perioperative period

时间窗: 2 weeks after operation

次要结局

  • The Modified Rankin Scale (MRS) score(at 90 days postoperation and at 1 year after operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heng Yang

Department of neurosurgery

Huashan Hospital

相似试验