NCT06823128终止不适用
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Severe Stenosis or Occlusion of Anterior Intracranial Circulation Vessels
The First Affiliated Hospital of University of Science and Technology of China1 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2025年4月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- Distribution of 90-day mRS scores
研究概览
简要总结
The primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is 18 years old or above.
- •Severe stenosis (70% - 99%) or occlusion of anterior intracranial circulation vessels, mainly including the intracranial segment of the internal carotid artery, middle cerebral artery (M1, M2) and anterior cerebral artery (A1, A2), which is confirmed by digital subtraction angiography (DSA), computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
- •Patients with clinically diagnosed acute ischemic stroke who received remote ischemic treatment within 72 hours after the onset.
- •The NIHSS score ranges from 4 to
- •The mRS score before stroke is less than or equal to
- •informed consent.
排除标准
- •Patients with vessel recanalization after mechanical thrombectomy (TICI grade ≥ 2b).
- •Patients planning to receive intracranial endovascular treatment within 3 months.
- •Patients diagnosed with acute posterior circulation cerebral infarction.
- •Symptoms caused by non - culprit vessels.
- •Ipsilateral extracranial vessel stenosis ≥ 70%.
- •Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and uncontrollable by antihypertensive drugs.
- •Intracranial tumors, arteriovenous malformations or aneurysms.
- •Cerebral venous thrombosis or stenosis.
- •Severe coagulation abnormalities.
- •Any contraindications to remote ischemic conditioning: severe soft tissue injury, fracture or vascular injury of the upper limb, perivascular lesions of the distal upper limb, etc.
- •Patients with any serious diseases and a life expectancy of less than 1 year.
- •Patients who participated in other clinical trials within 3 months before enrollment or are currently participating in other clinical trials.
- •Patients who cannot be followed up (such as those without a fixed residence, overseas patients, etc.).
- •Pregnant or lactating women.
- •Patients who have previously received remote ischemic treatment or similar treatments.
- •Patients whom the researchers consider unsuitable for this clinical study.
研究组 & 干预措施
RIC group+Guideline-based therapy
Experimental
RIC is given twice a day with 200mmHg pressure.
干预措施: Guideline-based therapy (Other)
RIC group+Guideline-based therapy
Experimental
RIC is given twice a day with 200mmHg pressure.
干预措施: RIC (Device)
Sham group+Guideline-based therapy
Active Comparator
RIC is given twice a day with 60mmHg pressure.
干预措施: Sham (Device)
Sham group+Guideline-based therapy
Active Comparator
RIC is given twice a day with 60mmHg pressure.
干预措施: Guideline-based therapy (Other)
结局指标
主要结局
Distribution of 90-day mRS scores
时间窗: 90±14 days after procedure
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
次要结局
- Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study)(90±14 days after procedure)
- Proportion of patients with functional independence outcome (mRS 0-1) at 90-day(90 (± 14 days) after procedure)
- Proportion of patients with functional independence outcome (mRS 0-2) at 90-day(90 (± 14 days) after procedure)
- Proportion of patients with functional independence outcome (mRS 0-3) at 90-day(90 (± 14 days) after procedure)
- The proportion of early neurological deterioration(7 (± 1 day) after procedure)
- Activities of Daily Living of Participants Assessed by Bathel Index at 90-day(90 (± 14 days) after procedure)
- Activities of Daily Living of Participants Assessed by Bathel Index at 360-day(360(± 14 days) after procedure)
- Incidences of adverse cardiovascular and cerebrovascular events, and recurrent ischemic events(360 (± 14 days) after procedure)
研究者
Wei Hu
Professor
The First Affiliated Hospital of University of Science and Technology of China
研究点 (1)
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