Regular Physical Activity in Patients With Symptomatic Intracranial Arterial Stenosis
- Conditions
- Ischemic StrokeTransient Ischemic Attack
- Registration Number
- NCT06615726
- Lead Sponsor
- Capital Medical University
- Brief Summary
The objective of this study is to evaluate the effectiveness and safety of regular physical activity in preventing ischemic stroke events in patients with symptomatic intracranial arterial stenosis.
- Detailed Description
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 activity 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 activity 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 activity 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 activity and stroke recurrence rates within 1 year in patients with symptomatic ICAS.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method New ischemic stroke events 1 year
- Secondary Outcome Measures
Name Time Method The score of min montreal cognitive assessment(range, 0 to 15, with higher scores indicating greater cognition) 1 year 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 Euro-QoL-5 Dimension(range, 0 to 100, with higher scores indicating better quality of life) 1 year
Trial Locations
- Locations (58)
Taihe Hospital of Traditional Chinese Medicine
🇨🇳Fuyang, Anhui, China
Huainan Sunshine Xinkang Hospital
🇨🇳Huainan, Anhui, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Anhui, China
The Second People's Hospital of Wuhu
🇨🇳Wuhu, Anhui, China
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Pinggu District Hospital
🇨🇳Beijing, Beijing, China
Chongqing Sanbo Jiangling Hospital
🇨🇳Chongqing, Chongqing, China
Zhangzhou Hospital
🇨🇳Zhangzhou, Fujian, China
Foshan Fifth People's Hospital
🇨🇳Foshan, Guangdong, China
Foshan Nanhai District Sixth People's Hospital
🇨🇳Foshan, Guangdong, China
Scroll for more (48 remaining)Taihe Hospital of Traditional Chinese Medicine🇨🇳Fuyang, Anhui, ChinaZongtao LiuContact15955861180liu236600@sina.com