Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke (RICAS): a Prospective, Randomized, Blind Endpoint, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The proportion of collateral status improvement.
研究概览
简要总结
The goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology.
详细描述
Stroke is the second leading cause of death and the third leading cause of death and disability combined in the world. The remote ischemic preconditioning (RIC) procedure is low-cost with excellent properties of safety, tolerability and feasibility in both AIS and cardiovascular diseases. In this study, we aim to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology. The RICAS study is a prospective, randomized, blind endpoint, multicenter study. Eligible patients with ischemic stroke of anterior circulation with large artery atherosclerosis etiology, poor collateral compensation, and more than 1 month of the symptom onset, are randomly assigned into the experimental group and control group with a ratio of 1:1. The patients in experiment group will receive treatment with RIC for 1 year as an adjunct to guideline-based treatment, while patients in control group only receive guideline-based treatment. The primary outcome is proportion of collateral status improvement, which is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization. The safety outcomes include RIC-related adverse events. A maximum of 300 patients (150 participants per group) are required to test the superiority hypothesis with 80% power (using a two-sided α = 0.05) to detect the 15% difference. The primary endpoint will further be stratified by age, gender, inclusion event (acute ischemic stroke ore transient ischemic stroke), tandem lesion, history of hypertension, hypercholesterolemia, diabetes mellitus, ischemic stroke, transient ischemic attack, and myocardial infarction. This study will provide the direct evidence for improvement of collateral status by chronic RIC 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age over 40 years old;
- •2. Diagnosed with ischemic stroke (including TIA and cerebral infarction), with onset time of more than 1 month;
- •3. Culprit arteries are the large arteries of the anterior circulation with atherosclerotic stenosis (≥50%) or occlusion;
- •4. ASITN/SIR collateral circulation of 0-3 based on DSA evaluation;
- •5. First onset or prior onset with no significant sequelae (mRS ≤ 2);
- •6. Those who are not expected to undergo angioplasty within 12 months (judged by the doctor or decided by patients and/or their representatives);
- •7. The availability of informed consent.
排除标准
- •1) Patients with severe infection or serious diseases such as liver, kidney, hematopoietic system, endocrine system, etc.;
- •2) Patients with a history of stroke and severe sequelae (mRS≥3);
- •3) arterial stenosis due to aortic dissection, moyamoya disease; Any known vasculitic disease; herpes zoster, varicella-zoster or other viral infections with vascular lesions; neurosyphilis; other intracranial infections; any intracranial artery stenosis associated with hypercytosis of cerebrospinal fluid; radiation-induced vascular lesions; myofiber dysplasia; sickle cell disease; neurofibromas; benign vascular lesions of the central nervous system; postpartum vascular disease; stenosis of the intracranial arteries due to vasospasm or thrombosm;
- •4) Uncontrolled severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110 mmHg after drug treatment) ;
- •5) Subclavian artery stenosis ≥50% or subclavian artery steal syndrome;
- •6) Patients with intracranial hemorrhage (parenchymal hemorrhage, subarachnoid hemorrhage, subdural/epidural hemorrhage) within 90 days before enrollment;
- •7) Intracranial tumor, arteriovenous malformation, or aneurysm;
- •8) Patients with severe hematologic diseases or severe coagulation abnormalities;
- •9) Retinal hemorrhage or visceral hemorrhage within 30 days;
- •10) Those who are expected to undergo major surgery (including femoral artery, cardiac, aortic or carotid artery surgery) within 30 days before enrollment or within 12 months after enrollment;
- •11) Those who have received stent implantation, angioplasty or other related medical devices for the target diseased blood vessels, or those who are expected to undergo the above treatments within 12 months after enrollment;
- •12) Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.
- •13) Damage and lesions in the cerebral veins;
- •14) Pregnant or lactating women;
- •15) Those who are participating in other clinical trials within 3 months;
- •16) Life expectancy is less than 1 year
- •17) Patients not suitable for this clinical studies considered by researcher
结局指标
主要结局
The proportion of collateral status improvement.
时间窗: 12 months
collateral status improvement is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization.
次要结局
- Influence on kidney function(12 months)
- RIC-related adverse events(12 months)
- The influence of RIC to neurological functions(12 months)
- Composite vascular events(12 months)
- Influence on heart function(12 months)
- Recurrence of nonfatal ischemic stroke in 12 months(12 months)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region