The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Blood Pressure and Heart Rates;
研究概览
简要总结
This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.
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 (Outcomes Assessor)
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
- •Patients with stroke or transient ischemic attack (TIA) within 180 days and the neurologic deficits were well matched to the territory of the stenosed artery, with intracranial arterial stenosis of at least 50% by angiography, at least 70% by ultrasound, or at least 70% by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA)
- •Age between 18 to 80 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-
- •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
- •Patients who did not complete the whole treatment procedure.
结局指标
主要结局
Blood Pressure and Heart Rates;
时间窗: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment
Plasma Biomarkers of Coagulation and Fibrinolysis
时间窗: the time points of baseline and 1, 15 and 30 days after BLIPC treatment
blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer
Number of Patients Who Got New Brain Lesions
时间窗: 300 days after treatment
We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)
次要结局
- The Time Point Until the First Stroke Recurrence,(At the 300-day after the initial treatment)
- Brain Perfusion Improvement Are Evaluated With SPECT and TCD(300-day after treatment)
研究者
Ji Xunming
Xuan Wu Hospital
Capital Medical University