Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis (RICSICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center 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
- time to the first occurrence of any component of the composite endpoint within 12 months post-randomization
研究概览
简要总结
Remote ischemic conditioning (RIC) has emerged as a promising non-invasive strategy to protect the brain, with evidence suggesting its benefit in patients with carotid artery stenting (CAS). However, the long-term benefit and safety of chronic RIC in this population remain unknown. This trial aims to evaluate whether chronic RIC reduces the incidence of major vascular events and improves clinical outcomes in high-risk patients with carotid artery stenosis who received CAS.
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
- •Age ≥ 40 years old;
- •Patients with symptomatic moderate to severe stenosis of the internal carotid artery;
- •History of ipsilateral cerebral ischemic symptoms within the past 180 days;
- •Planned for carotid artery stent;
- •Essen Score ≥ 3;
- •Modified Rankin Scale score of 0 or 1;
- •Signed informed consent.
排除标准
- •Uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg despite medication)
- •Subclavian artery stenosis ≥ 50% or presence of subclavian steal syndrome
- •Severe hematological disorders or significant coagulation abnormalities
- •Contraindications to remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limbs, or peripheral vascular disease in the distal upper limbs
- •Severe comorbid conditions with a life expectancy of less than 1 year
- •Participation in another clinical trial within the past 3 months or ongoing participation
- •Any other circumstances deemed by the investigator as unsuitable for participation in this clinical study.
研究组 & 干预措施
RIC group
The RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure.
干预措施: Remote ischemic conditioning (Device)
Control group
no RIC treatment
结局指标
主要结局
time to the first occurrence of any component of the composite endpoint within 12 months post-randomization
时间窗: 1 year
the composite endpoint includes ischemic stroke, hemorrhagic stroke, myocardial infarction \[including coronary revascularization\], TIA, or vascular death
次要结局
- occurrence of contrast staining on brain computerized tomography(1 hours and 24 hours after carotid artery stenting)
- occurrence of cerebral hyperperfusion syndrome(24 hours after carotid artery stenting)
- occurence of new infarct on brain magnetic resonance imaging(24 hours after carotid artery stenting)
- change in collateral circulation status (assessed by Computed Tomography Angiography or Digital Subtraction Angiograph) from baseline to 12 months(1 year)
- all-cause mortality(1 year)
- composite of periprocedural death, stroke, or myocardial infarction(30±3 days)
- occurence of non-fatal stroke and TIA(1 year)
- occurence of nonfatal myocardial infarction(1 year)
- numbers of new silent cerebral infarcts on Magnetic Resonance Imaging(1 year)
- occurence of ipsilateral (to the stented artery) nonfatal stroke and transient ischemic attack(1 year)
- degree of in-stent restenosis (≥50%) on Computed Tomography Angiography(1 year)
- changes in modified Rankin Scale (mRS) scores over time(1 year)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region