Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 主要终点
- Local tissue damage 30 days after RIPC treatment
研究概览
简要总结
Stroke is one of the three leading causes of human death, and a major cause of adult disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction. Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients.
详细描述
This study explored the neuroprotective effects of post-positioning on ischemic stroke patients with randomized, double-blinded and controlled method. Patients are divided into experimental and placebo groups to receive remote ischemic post-conditioning for 30 days. Remote ischemic post-conditioning is performed by the inflating tourniquets to certain extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group. Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days after treatment; and MRI at 0 and 30 days after treatment.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 40 to 80 Years
- •Ischemic cerebrovascular disease within 6 hours
- •National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4
- •Cranial CT to rule out the the cerebral hemorrhage
- •Written informed consent was
排除标准
- •Cerebral hemorrhage
- •Other parts of the active bleeding disease
- •Atrial fibrillation
- •Moyamoya disease or vasculitis
- •Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy
- •Out coagulation disorder
- •Severe lesions of severe liver and kidney disease, malignancy or other systemic
- •Cannot tolerate BLIPC or without informed consent
结局指标
主要结局
Local tissue damage 30 days after RIPC treatment
时间窗: 30 days after RIPC treatment
Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage
Levels of plasma biomarkers assay right before RIPC treatment
时间窗: right before RIPC treatment (within 24hrs)
levels of CRP、TINF-α、slCAM-1 and GFAP
Levels of plasma biomarkers assay 3 days after RIPC treatment.
时间窗: 3 days after RIPC treatment.
levels of CRP、TINF-α、slCAM-1 and GFAP
Levels of plasma biomarkers assay 15 days after RIPC treatment.
时间窗: 15 days after RIPC treatment.
levels of CRP、TINF-α、slCAM-1 and GFAP
Levels of plasma biomarkers assay 30 days after RIPC treatment
时间窗: 30 days after RIPC treatment
levels of CRP、TINF-α、slCAM-1 and GFAP
Levels of plasma biomarkers assay right after RIPC treatment
时间窗: right after RIPC treatment (within 24hrs)
levels of CRP、TINF-α、slCAM-1 and GFAP
次要结局
- Infarct volume evaluation before RIPC treatment.(Acute phase of ischemic stroke, and before RIPC treatment)
- Infarct volume after RIPC treatment in ischemic stroke patients(30 days after RIPC treatment in ischemic stroke patients)
研究者
Ji Xunming
Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University
Capital Medical University