Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: a Prospective Randomized Open-label Blinded Endpoint Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,300
- 试验地点
- 58
- 主要终点
- New ischemic stroke events
研究概览
简要总结
The objective of this study is to evaluate the effectiveness and safety of regular physical exercise in preventing ischemic stroke events in patients with symptomatic intracranial arterial stenosis.
详细描述
The intracranial atherosclerotic stenosis (ICAS) is a common cause of ischemic stroke, and the result of increasing global burden of stroke. There are significant racial differences in the incidence of ICAS, which account for 8%-10% of stroke causes in North America and 30%-50% in Asia. In China, the incidence of ICAS in patients with ischemic stroke or transient ischemic attack (TIA) is as high as 46.6%. Previous studies have shown that stroke patients with ICAS have more severe symptoms, longer hospital stay and higher stroke recurrence rate, and the recurrence rate of stroke increases with the increase of stenosis degree. In the WASID (Warfarin-Aspirin Symptomatic Intracranial Disease trial and several prospective cohort studies) trial, the risk of recurrent stroke remained high even after aggressive medication and risk factor intervention in ICAS patients.
At present, the treatment of ICAS mainly includes drug therapy and endovascular therapy. Both the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial in 2011 and the VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial in 2015, showed that aggressive medical treatment is more effective and safer than endovascular treatment . A 2018 review comparing stenting versus aggressive medical treatment for symptomatic ICAS also noted that medical treatment remains the preferred treatment for symptomatic ICAS patients compared to endovascular therapy. The results of the CASSISS trial in 2022, showed that endovascular therapy failed to show long-term benefit in severe patients with symptomatic ICAS. However, the above trials also found that even with aggressive medical treatment including dual antiplatelet therapy and intensive management of vascular risk factors, the one-year stroke recurrence rate in patients with symptomatic ICAS is still as high as 20%. This seriously endangers national lives and health, and restricts social and economic development. Therefore, there is an urgent need to explore new treatments to improve patient survival.
Several previous studies have shown that physical exercise can reduce the incidence of all-cause stroke, cardiovascular disease and death, but little is known whether it can reduce the recurrence rate of stroke in patients with symptomatic ICAS. A subgroup analysis of the 2016 SAMMPPRIS trial found that in high-risk symptomatic ICAS patients, physical exercise significantly reduced the likelihood of recurrent stroke, myocardial infarction, or vascular death. A 2023 cross-sectional study that included NOMAS (Northern Manhattan Study) data showed a strong negative association between physical exercise and asymptomatic high-risk ICAS and was not regulated by vascular risk factors. Therefore, this trial conducts a multicenter, randomized, controlled, blinded trial of patients with symptomatic ICAS within 30 days to compare them with a control group that received only secondary stroke prevention health education to determine the association between regular physical exercise and stroke recurrence rates within 1 year in patients with symptomatic ICAS.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Inclusion criteria:
- •Age ≥40 years and ≤80 years;
- •Ischemic stroke or TIA (transient ischemic attack) onset ≤30 days;
- •Ischemic stroke or TIA is attributed to 50-99% of the ICAS (internal carotid artery, M1 segment of middle cerebral artery, M2 segment of middle cerebral artery, basilar artery, or vertebral artery; the degree of stenosis is determined by magnetic resonance angiography, computed tomography angiography, digital subtraction angiography using the standards of warfarin-aspirin symptomatic intracranial disease );
- •mRS (modified Rankin Scale)≤4;
- •The patient himself or his legal representative signs the informed consent form.
排除标准
- •Stroke progression within the past 3 days (defined as an increase in the score of National Institute of Health Stroke Scale ≥4 points or an increase in individual items of ≥2 points).
- •mRS≥1 before the stroke onset.
- •Concurrent osteoarthritis, fracture, lower limb venous thrombosis, unstable angina pectoris, respiratory diseases, limb disabilities, etc., making it theoretically difficult to cooperate with the physical activity plan for this trial.
- •Complicated with motor disorders such as Parkinson's disease and Parkinson's syndrome.
- •The vessels responsible for this stroke had tandem lesions (more than 50% of extracranial artery stenosis).
- •The vessel responsible for this stroke has undergone intracranial balloon angioplasty and/or stent implantation (except for mechanical thrombectomy and/or aspiration alone).
- •It is expected that intracranial arterial balloon angioplasty and/or stent implantation will be performed on the vessel responsible for the stroke within 3 months.
- •Patients who exercised regularly within the last 6 months. Regular exercise is defined as four or more moderate intensity exercises per week for more than 10 minutes each time or two or more high intensity exercises per week for more than 10 minutes each time.
- •Inability to understand and/or comply with the trial procedures and/or follow-up due to mental illness, cognitive or emotional disorders.
- •Life expectancy is less than one year.
- •Women who are known to be pregnant or nursing, or have a positive pregnancy test;
- •Are participating in other drug or device research.
- •There are other circumstances that investigators consider are not suitable for enrollment.
结局指标
主要结局
New ischemic stroke events
时间窗: 1 year
次要结局
- New ischemic stroke and transient ischemic attack events in the responsible vessel supply area(1 year)
- New ischemic stroke and transient ischemic attack events(1 year)
- Hemorrhagic stroke event(1 year)
- Myocardial infarction(1 year)
- The proportion of modified Rankin Scale score 0-1 (range, 0 to 6, with higher scores indicating greater disability)(1 year)
- The score of min montreal cognitive assessment(range, 0 to 15, with higher scores indicating greater cognition)(1 year)
- The score of Euro-QoL-5 Dimension(range, 0 to 100, with higher scores indicating better quality of life)(1 year)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University