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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,300
After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.
Xuanwu Hospital, Capital Medical University
Beijing, China
RECRUITINGNew ischemic stroke events
Time frame: Within 3 years after randomization
New ischemic stroke and transient ischemic attack events in the responsible vessel supply area
Time frame: Within 3 years after randomization
New ischemic stroke and transient ischemic attack events
Time frame: Within 3 years after randomization
Hemorrhagic stroke events
Time frame: Within 3 years after randomization
Myocardial infarction events
Time frame: Within 3 years after randomization
Proportion of patients achieving modified Rankin Scale score (mRS) 0-1
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\], with higher scores indicating greater disability)
Time frame: At 3 years after randomization
The score of mini-Montreal Cognitive Assessment
The score of mini-Montreal Cognitive Assessment (range, 0 to 15, with higher scores indicating greater cognition)
Time frame: At 3 years after randomization
Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L)
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= n
Time frame: At 3 years after randomization
Rate of Falls
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Time frame: Within 3 years after randomization
All-cause death
Time frame: Within 3 years after randomization