Safety and Efficacy of Remote Ischemic Conditioning in Patients With Chronic Cerebral Artery Occlusion: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of cerebral blood flow perfusion
研究概览
简要总结
Chronic cerebral artery occlusion (CCAO), which is characterized by the pathophysiological change of long-term cerebral hemodynamic disorder, is one of the major risk factors affect the occurrence and recurrence of ischemic stroke. However, the mechanism of CCAO injury is not clear and effective treatment is warranted. The purpose of this study is to investigate the protective effect and underlying mechanism of remote ischemic conditioning (RIC) on CCAO.
详细描述
CCAO is a cerebrovascular disease due to cerebral hypo-perfusion. It is often associated with repeated ischemic stroke or transient neurological symptoms, progressive cognitive decline and reduction of daily ability. Specific and effective treatment is warranted for symptomatic management of CCAO. RIC is a non-invasive strategy to protect the brain. The clinical trials have demonstrated that daily limb RIC seems to be potentially effective in patients with symptomatic intracranial arterial stenosis in cerebral blood flow and metabolism. RIC can also ameliorate cerebral small vessel disease in slowing cognition decline and reducing white matter. Therefore, it is worth to investigate the neuroprotective mechanism of RIC for CCAO.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age range 40-80 years, regardless of gender;
- •(2) Digital angiography (DSA) / ultrasound / CT angiography (CTA) / magnetic resonance angiography (MRA) showed unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion and stenosis of any other cerebral arteries (e.g. the other side of ICA or MCA, basilar artery) < 50%;
- •(3) Modified Rankin Scale (mRS) score 0-2;
- •(4) Symptoms of ischemic cerebrovascular disease (ischemic stroke or TIA) due to ICA or MCA occlusions within 12 months prior to enrollment;
- •(5) neurological deficits were stable ≥ 30 days after occlusion;
- •(6) Magnetic resonance perfusion weighted imaging (PWI) showed mean transit time (MTT) ≥ 4s and related cerebral blood flow (rCBF) (symptomatic side/asymptomatic side) < 0.95;
- •(7) The subject or its legally authorized representative is able to provide informed reports.
排除标准
- •(1) Uncontrolled hypertension despite the use of antihypertensive drugs before enrollment (defined as systolic blood pressure ≥200mmHg);
- •(2) Stenosis or occlusion of subclavian artery and upper limb artery;
- •(3) Previous history of cerebral hemorrhage, including intracranial hemorrhage, ischemic stroke hemorrhage transformation, vascular malformation or intracranial tumor or other parts of the active bleeding disease;
- •(4) History of brain tumor or mental illness or acute stroke ≤6 months;
- •(5) Suffering from cardiogenic thrombosis diseases, such as mitral stenosis and atrial fibrillation, myocardial infarction, mural thrombosis or valvular vegetations, congestive heart failure or endocarditis within six months;
- •(6) Obvious disorder of coagulation mechanism;
- •(7) Severe liver or kidney insufficiency, malignant tumor, or serious diseases requiring medical intervention or surgery;
- •(8) There is soft tissue or blood vessel injury at the cuff compression site of RIC treatment, or other conditions that cannot tolerate RIC;
- •(9) Pregnant or lactating women;
- •(10) Life expectancy <6 months;
- •(11) Refusal to sign informed consent, poor compliance, or inability to complete complete treatment, etc.
结局指标
主要结局
Change of cerebral blood flow perfusion
时间窗: 180 days
The investigators evaluate the change of perfusion capacity of cerebral blood vessels on PWI-MRI.
次要结局
- Recurrence times of stroke or transient ischemic attack (TIA)(180 days)
- Adverse events related to RIC treatment(From baseline to 180-day treatment)
- Change of the Verbal Fluency Test (VFT) score(180 days)
- Change of the Digit Span Forward and Backward score(180 days)
- Change of the Hamilton Depression-17 (HAMD-17) scale(180 days)
- Change of the Hamilton Anxiety (HAMA) scale(180 days)
- Changes of volume of WMHs(180 days)
- Change of the direction of white matter cellulose(180 days)
- Change of cerebral hemoglobin oxygenation status(180 days)
- Change of collateral circulation(180 days)
- Change of the Montreal Cognitive Assessment (MoCA) score(180 days)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University