Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- New ischemic stroke events
研究概览
简要总结
This study will include the subjects with symptomatic intracranial arterial stenosis (ICAS) who have participated in and completed the 1-year follow-up of RESIST trial (NCT06615726). The aim is to observe the long-term clinical outcomes over 3 years after a 1-year regular physical exercise intervention in patients with symptomatic ICAS.
详细描述
This is a non-interventional, observational study designed to investigate long-term clinical outcomes in symptomatic ICAS patients who have already enrolled in RESIST trial and completed the 1-year follow-up.
After completing 12-month randomized intervention from RESISR trial, investigators continue to follow the subjects up to 3 years without any further intervention or changes to routine clinical management. The primary endpoint is the incidence of new ischemic stroke within 3 years. Secondary endpoints include new ischemic stroke and transient ischemic attack events in the responsible vessel supply area within 3 years; new ischemic stroke and transient ischemic attack events within 3 years; hemorrhagic stroke event within 3 years; myocardial infarction within 3 years; falls within 3 years; all-cause death within 3 years; the proportion of patients with modified Rankin Scale score 0-1 at 3 years; the score of mini-Montreal Cognitive Assessment at 3 years; and the score of EuroQol 5-Dimension 5-Level at 3 years.
Approximately 1,300 subjects who have completed the RESIST trial's 1-year follow-up and consented to continue will be included. The overall study duration will extend from the first participant's entry into the observation period until the last participant completes the 3-year follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants who enrolled in the RESIST trial and completed the 12-month follow-up.
- •Written informed consent to participate in this 3-year observational extension.
排除标准
- •Participants who withdrew consent in the RESIST trial, decline to participate in this extension, or were lost to follow-up at 12 months.
研究组 & 干预措施
Regular Physical Exercise Group
Participants with symptomatic ICAS who were assigned to the regular physical exercise intervention in the RESIST trial and completed the 12-month follow-up.
干预措施: Non-Interventional Study (Other)
Control Group
Participants with symptomatic ICAS who were assigned to the control group in the RESIST trial and completed the 12-month follow-up.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
New ischemic stroke events
时间窗: Within 3 years after randomization
次要结局
- New ischemic stroke and transient ischemic attack events in the responsible vessel supply area(Within 3 years after randomization)
- New ischemic stroke and transient ischemic attack events(Within 3 years after randomization)
- Hemorrhagic stroke events(Within 3 years after randomization)
- Myocardial infarction events(Within 3 years after randomization)
- Proportion of patients achieving modified Rankin Scale score (mRS) 0-1(At 3 years after randomization)
- The score of mini-Montreal Cognitive Assessment(At 3 years after randomization)
- Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L)(At 3 years after randomization)
- Rate of Falls(Within 3 years after randomization)
- All-cause death(Within 3 years after randomization)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University
