Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615726
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Regular Physical Activity in Patients With Symptomatic Intracranial Arterial Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Regular Physical Activity in Patients With Symptomatic Intracranial Arterial Stenosis a Prospective Randomized Open-label Blinded Endpoint Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESIST
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 466 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None