Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- objective signs of tissue or neurovascular injury
研究概览
简要总结
Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 80 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 80 to 95 years old
- •Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
- •National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4
- •ABCD2 score between 6 to 7
- •stable vital signs, normal hepatic and renal functions
- •no hemorrhagic tendencies
排除标准
- •within 72 hrs of intra-artery or intravenous thrombolysis
- •intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
- •any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
- •acute myocardial infarction
- •systolic blood pressure more than 200 mmHg after drug control
- •peripheral blood vessel disease
- •hematologic disease
- •severe hepatic and renal dysfunction
- •severe or unstable concomitant disease
- •cannot tolerate BLIPC or without informed consent
结局指标
主要结局
objective signs of tissue or neurovascular injury
时间窗: 180 days after treatment
objective signs of tissue or neurovascular injury felt to be due to cuff inflation, which was based on the judgment of the observers (blinded to study protocol) precluded continuation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
levels of plasma biomarkers
时间窗: 180-day
levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored
次要结局
未报告次要终点
研究者
Ji Xunming
Professor
Capital Medical University