Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean Change of Collateral Circulation from Baseline and at 6 months
研究概览
简要总结
The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.
详细描述
Stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. And more and more young patients account for the increasing morbidity. Among them, Symptomatic intracranial atherosclerotic stenosis（sICAS）is a major cause, especially in Asians.
Currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. Therefore, other treatment methods are called for urgently. Remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. Prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. However, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial.
Thus, the EPIC-sICAS trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral Infarction. Hopefully to present us a very meaningful way to improve the patient's quality of life.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 45 Years old;
- •Symptomatic intracranial atherosclerotic stenosis (sICAS): cranial CTA/MRA/TCD/DSA confirm the diagnosis, patients got ischemic stroke or transient ischemic attack in the brain region supplied by the stenosis artery;
- •National Institutes of Health Stroke Scale(NIHSS) score 0-15
- •Written informed consent was signed.
排除标准
- •Cerebral hemorrhage and other parts of the active bleeding disease;
- •Severe aphasia, unable to express himself;
- •A history of brain tumor, brain trauma, cerebral embolism or other brain lesions;
- •Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction;
- •Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment;
- •Dementia and mental illness;
- •Using angiotensin-converting enzyme inhibitors;
- •A history of major surgery or trauma 4 weeks prior to admission;
- •Without informed consent.
- •Elimination Criteria：
- •Patients with poor compliance，refuse to take regular treatment and examination;
- •patients' condition get exacerbated, with NIHSS score elevate for more than 4.
结局指标
主要结局
Mean Change of Collateral Circulation from Baseline and at 6 months
时间窗: Baseline and at 6 months
Collateral circulation measured in iconography test: Magnetic Resonance Angiography (MRA)、 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)、Arterial spin-labeled (ASL) perfusion magnetic resonance、Transcranial Cerebral Doppler (TCD)、single photon emission computed tomography（SPECT） Baseline was defined as the onset of stroke within 48h. A higher score represents better collateral circulation status functioning.
次要结局
- Mean Change of Symptomatic Recovery(Baseline and at 14 days, 1 month, 6 months, and 1 year)
- Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days.(Baseline and at 10 days)
研究者
Meng Wei
Director, Clinical Research
Health Science Center of Xi'an Jiaotong University