NCT02971462Unknown不适用
Remote Ischemic Conditioning for Reducing Stroke Risk of Symptomatic Vertebrobasilar Lesion of Atherosclerosis
Ji Xunming0 个研究点目标入组 80 人开始时间: 2016年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- number of ischemic cerebrovascular events with vertebrobasilar responsibility
研究概览
简要总结
The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Male or female with age from 18 to 80 years old.
- •Patients having an ischemic stroke or a TIA within 30 days and with mRS score≤4 prior to randomization.
- •The entry event is attributed to symptomatic atherosclerotic lesion（stenosis is greater than or equal to 50% or occlusion）in vertebrobasilar artery that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
- •Informed consent obtained.
排除标准
- •Thrombolytic therapy within 24 hours prior to enrollment.
- •Progressive neurological signs within 24 hours prior to enrollment.
- •Cerebral venous thrombosis/stenosis.
- •vertebrobasilar lesions due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other infection; any artery stenosis associated with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus.
- •Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with the participation.
- •Uncontrolled severe hypertension [sitting systolic blood pressure (SBP) >180 mmHg and/or sitting diastolic blood pressure (DBP) >110 mmHg after medication].
- •Patients with serious complications or abnormal laboratory parameters: aspartate transaminase (AST) and/or alanine transaminase (ALT) >3×upper limit of normal range; creatinine clearance <0.6 ml/s and/or serum creatinine >265 μmol/l (>3.0 mg/dl); platelets <100×109/L.
- •Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment.
- •Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.
- •Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.
- •Severe hemostatic disorder or severe coagulation dysfunction.
- •Subclavian arterial stenosis≥50% or subclavian steal syndrome.
- •Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures within 12 months after enrollment.
- •Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 6 months after enrollment.
- •Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
- •Pregnant or breast-feeding women.
- •Unwilling to be followed up or poor compliance for treatment.
- •Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
- •Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
研究组 & 干预措施
RIC group
Experimental
Experimental: RIC group The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 1 month after stroke. In addition, all participants receive a standard clinical therapy.
干预措施: ischemic conditioning (Device)
Control group
No Intervention
The participants receive a standard clinical therapy after diagnosed ischemic stroke.
结局指标
主要结局
number of ischemic cerebrovascular events with vertebrobasilar responsibility
时间窗: 0-6 months from randomization
ischemic cerebrovascular events include ischemic stroke and transient ischemic attack
次要结局
- number of participants with mRS 0-1(0-6 months from randomization)
- number of composite outcomes events(0-6 months from randomization)
- Number of participants with adverse events that are related to treatment(0-6 months from randomization)
- changes of plasma biomarkers(baseline，3 and 6 months)
- changes of hemodynamics(0-6 months from randomization)
研究者
Ji Xunming
VP,Professor
Capital Medical University
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